510(k) K033326 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
| Applicant | Philips Medical Systems, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 29, 2003 |
| Received | Oct 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2026 | Philips North America Llc Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x Open, Classified |
JAK | None listed |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance CT 40 Channel, Model Number: 728235.
2. Brilliance CT 64 Channel, Model Number: 728231.
3. Ingenuity Flex, Model Number: 728317 Open, Classified |
JAK | None listed |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity Core128 / Elite China, Model Number: 728324. Open, Classified |
JAK | None listed |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Ingenuity CT Family Brazil, Model Number: 728325. Open, Classified |
JAK | None listed |
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. CT 6000, Model Number: 728307. Open, Classified |
JAK | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
Brilliance 64, Brilliance 40, Ingenuity Flex
728235 - Brilliance 40
728 Open, Classified |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64, Model 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at dif Terminated |
JAK | None listed |
| Oct 18, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 40, Model 728235
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at diff Terminated |
JAK | None listed |
| Jul 3, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64, 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different Terminated |
JAK | None listed |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system Terminated |
JAK | None listed |
| Feb 21, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 with 4.1.7 XX026 software version model number 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstru Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction o Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer rec Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction o Terminated |
JAK | None listed |
| Nov 10, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance 64, (Code 728231)
Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 728231
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 728232
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Aug 24, 2016 | Philips Medical Systems Brilliance 64 CT Model Number 728231
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data take Terminated |
JAK | None listed |
| Aug 24, 2016 | Philips Medical Systems Ingenuity Core Model Number 728321
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken a Terminated |
JAK | None listed |
| Aug 24, 2016 | Philips Medical Systems Ingenuity Core 128 Model Number 728323
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data ta Terminated |
JAK | None listed |
| Aug 24, 2016 | Philips Medical Systems Ingenuity CT Model Number 728326
Product Usage:
Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 CT Model number 728231
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data take Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core, Model number 728321
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken Terminated |
JAK | None listed |
| Jul 20, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128, Model number 728323
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data ta Terminated |
JAK | None listed |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. Terminated |
JAK | None listed |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. Terminated |
JAK | None listed |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Apr 8, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray Systems
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles a Terminated |
JAK | None listed |
| Apr 8, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray Systems,
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angl Terminated |
JAK | None listed |
| Apr 8, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray Systems
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different ang Terminated |
JAK | None listed |
| Apr 8, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Computed Tomography X-ray Systems
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and p Terminated |
JAK | None listed |
| Apr 1, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64, Computed Tomography X-ray system
Product Usage:
The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by Terminated |
JAK | None listed |
| Apr 1, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core-Computed Tomography X-ray system
Product Usage:
The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by co Terminated |
JAK | None listed |
| Apr 1, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128-Computed Tomography X-ray system
Product Usage:
The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the bo Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Mar 24, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane Terminated |
JAK | None listed |
| Mar 4, 2016 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH.
Provides software applications used to process, analyze, and display medical images/data. Terminated |
JAK | None listed |
| Feb 5, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Feb 5, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray Systems,
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Feb 5, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Feb 5, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray system Terminated |
JAK | None listed |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray system Terminated |
JAK | None listed |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray system Terminated |
JAK | None listed |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Computed Tomography X-ray system Terminated |
JAK | None listed |
| Dec 10, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dat Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Jul 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence technology.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken Terminated |
JAK | None listed |
| Jul 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Ingenuity Core.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Jul 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Ingenuity Core 128.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes Terminated |
JAK | None listed |
| Jul 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Ingenuity CT scanners.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla Terminated |
JAK | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at differ Terminated |
JAK | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems.
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at di Terminated |
JAK | None listed |
| Jul 22, 2015 | Philips Medical Systems (Cleveland) Inc Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 64.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance CT 40.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity CT.
Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Terminated |
JAK | None listed |
| Apr 14, 2015 | Philips Electronics North America Corporation Philips Healthcare Brilliance 64 Computed Tomography X-ray system Terminated |
JAK | None listed |
| Apr 14, 2015 | Philips Electronics North America Corporation Philips Healthcare Ingenuity Core Computed Tomography X-ray system Terminated |
JAK | None listed |
| Apr 14, 2015 | Philips Electronics North America Corporation Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system Terminated |
JAK | None listed |
| Apr 14, 2015 | Philips Electronics North America Corporation Philips Healthcare Ingenuity CT Computed Tomography X-ray system Terminated |
JAK | None listed |
| Apr 1, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Clevela Terminated |
JAK | None listed |
| Jan 15, 2015 | Philips Medical Systems (Cleveland) Inc Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package
Product Usage:
Intended to produce cross-sectional images of the body by computer reconstruction of X-ray tran Terminated |
JAK | None listed |
| Sep 29, 2014 | Philips Medical Systems (Cleveland) Inc The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm Terminated |
JAK | None listed |
| Sep 26, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit.
Computed tomography scanner intended to provide cross sectional images of the human body and visualization of Terminated |
JAK | None listed |
| Sep 18, 2014 | Philips Medical Systems (Cleveland) Inc The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different Terminated |
JAK | None listed |
| Aug 14, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT
IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server Terminated |
JAK | None listed |
| Jun 4, 2014 | Philips Medical Systems (Cleveland) Inc Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners) Terminated |
JAK | None listed |
| Jun 2, 2014 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin Terminated |
KPS | None listed |
| Apr 16, 2014 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc. Terminated |
KPS | None listed |
| Apr 16, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Terminated |
JAK | None listed |
| Jan 29, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, Brilliance 64 and Brilliance Big Bore
The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the Terminated |
JAK | None listed |
| Sep 16, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143.
Intended to produce cross-sectional i Terminated |
JAK | None listed |
| Jul 2, 2013 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray systems
Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce c Terminated |
JAK | None listed |
| Jul 1, 2013 | Maquet Cardiovascular Us Sales, Llc MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05.
The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical Terminated |
LGX | None listed |
| Jun 25, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems.
Produce cross-sectional images of the body by computer reconstruction Terminated |
JAK | None listed |
| Mar 14, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the bod Terminated |
JAK | None listed |
| Mar 13, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems.
These devices are Computed Tomography X-Ray Systems that are int Terminated |
JAK | None listed |
| Jan 15, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Bri Terminated |
JAK | None listed |
| Aug 22, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components an Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.