510(k) K060937 ยท JAK System, X-Ray, Tomography, Computed
BRILLIANCE VOLUME
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Jun 5, 2006 |
| Received | Apr 5, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060937
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2025 | Philips North America Llc Philips CT systems labeled as the following:
1. Brilliance iCT SP, Model Number: 728311. Open, Classified |
JAK | None listed |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728306 - Brilliance iCT
728311 - Brilliance iCT SP Open, Classified |
JAK | None listed |
| Apr 13, 2021 | Philips North America Llc BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body.
Model Number: 728306 Terminated |
JAK | None listed |
| May 6, 2020 | Philips North America, LLC Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848 Terminated |
JAK | None listed |
| May 6, 2020 | Philips North America, LLC Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311 Terminated |
JAK | None listed |
| Feb 8, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance iCT - Model no. 728306 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 Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system
Product Usage:
Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstructio Terminated |
JAK | None listed |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare Brilliance iCT computed tomography x-ray system Terminated |
JAK | None listed |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare Brilliance iCT SP computed tomography x-ray system Terminated |
JAK | None listed |
| Jul 11, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP - Model 728311
Brilliance iCT - Model 728306 Computed Tomography X-ray systems Terminated |
JAK | None listed |
| Jul 11, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT - Model 728306 Computed Tomography X-ray systems Terminated |
JAK | None listed |
| Dec 23, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Terminated |
JAK | None listed |
| Nov 25, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT
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 angles Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-ray system, Model 728306 Terminated |
JAK | None listed |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance ICT SP Computed Tomography X-ray system, Model 728311 Terminated |
JAK | None listed |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT model #728306; Intended to produce cross- sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body. Terminated |
JAK | None listed |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. 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 iCT 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 Brilliance iCT SP 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 iCT Computed Tomography X-ray system Terminated |
JAK | None listed |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP Computed Tomography X-ray system Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Terminated |
JAK | None listed |
| Jul 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System.
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 24, 2015 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-ray Systems Brilliance iCT SP.
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 |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workstation (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 iCT (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 iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
JAK | None listed |
| May 29, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-ray system Terminated |
JAK | None listed |
| May 22, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance iCT.
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 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 |
| Dec 16, 2014 | Philips Medical Systems, Inc. Philips Brilliance iCT Computed Tomography X-Ray System
Product Usage:
The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body 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 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 |
| Jan 27, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance iCT and Brilliance iCT SP
These systems are 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 |
| Jan 27, 2014 | Philips Medical Systems (Cleveland) Inc Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH
The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to pro Terminated |
JAK | None listed |
| Nov 15, 2013 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-Ray System,
Product Usage:
The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstru 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 |
| Jul 19, 2012 | Philips Medical Systems (Cleveland) Inc Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems.
The devices are Computed Tomography Systems that are intended to produce cross-sectional images of th Terminated |
JAK | None listed |
| Jul 12, 2012 | Philips Medical Systems (Cleveland) Inc Intellispace Portal software
Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Terminated |
JAK | None listed |
| Jul 11, 2012 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal software and Extended Brillance Workspace software
Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical appli Terminated |
JAK | None listed |
| Jul 11, 2012 | Philips Medical Systems (Cleveland) Inc Intellispace Portal software.
Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Terminated |
JAK | None listed |
| Jun 8, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance iCT and iCT SP 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 angl Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #728326, CT Scanning Systems are subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Big Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingen Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction
Product Usage:
The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT S Terminated |
JAK | None listed |
| May 30, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance iCT and iCT SP 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 angl Terminated |
JAK | None listed |
| Mar 30, 2012 | Philips Medical Systems (Cleveland) Inc IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the e Terminated |
KPS | None listed |
| Jan 24, 2012 | Philips Medical Systems (Cleveland) Inc Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and In Terminated |
JAK | None listed |
| Sep 14, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating sof Terminated |
JAK | None listed |
| Sep 14, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version Terminated |
JAK | None listed |
| May 19, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3. Terminated |
JAK | None listed |
| Mar 16, 2011 | Philips Medical Systems (Cleveland) Inc Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brillianc Terminated |
KPS | None listed |
| Sep 22, 2010 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025
The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by co Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.