ClearanceBrief
510(k) K060937 ยท JAK System, X-Ray, Tomography, Computed

BRILLIANCE VOLUME

ApplicantPhilips Medical Systems (Cleveland), Inc., Cleveland OH, US
DecisionSubstantially Equivalent, Jun 5, 2006
ReceivedApr 5, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060937

DateFirm and productCodeLinked 510(k)
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Open, Classified
JAKNone listed
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Open, Classified
JAKNone listed
Apr 13, 2021Philips 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
JAKNone listed
May 6, 2020Philips North America, LLC
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
Terminated
JAKNone listed
May 6, 2020Philips North America, LLC
Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311
Terminated
JAKNone listed
Feb 8, 2018Philips 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
JAKNone listed
Feb 8, 2018Philips 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
JAKNone listed
Nov 8, 2017Philips Medical Systems (Cleveland) Inc
Philips Healthcare Brilliance iCT computed tomography x-ray system
Terminated
JAKNone listed
Nov 8, 2017Philips Medical Systems (Cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Terminated
JAKNone listed
Jul 11, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Terminated
JAKNone listed
Jul 11, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Terminated
JAKNone listed
Dec 23, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT
Terminated
JAKNone listed
Nov 25, 2016Philips 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
JAKNone listed
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system, Model 728306
Terminated
JAKNone listed
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Terminated
JAKNone listed
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Terminated
JAKNone listed
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Terminated
JAKNone listed
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Terminated
JAKNone listed
Mar 4, 2016Philips 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
JAKNone listed
Feb 5, 2016Philips 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
JAKNone listed
Feb 5, 2016Philips 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
JAKNone listed
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Terminated
JAKNone listed
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP Computed Tomography X-ray system
Terminated
JAKNone listed
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Terminated
JAKNone listed
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Terminated
JAKNone listed
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Terminated
JAKNone listed
Jul 24, 2015Philips 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
JAKNone listed
Jul 24, 2015Philips 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
JAKNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
JAKNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
JAKNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
JAKNone listed
May 29, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Terminated
JAKNone listed
May 22, 2015Philips 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
JAKNone listed
Apr 1, 2015Philips 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
JAKNone listed
Jan 15, 2015Philips 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
JAKNone listed
Dec 16, 2014Philips 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
JAKNone listed
Aug 14, 2014Philips 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
JAKNone listed
Jun 4, 2014Philips 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
JAKNone listed
Jun 2, 2014Philips 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
KPSNone listed
Apr 16, 2014Philips 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
JAKNone listed
Jan 29, 2014Philips 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
JAKNone listed
Jan 27, 2014Philips 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
JAKNone listed
Jan 27, 2014Philips 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
JAKNone listed
Nov 15, 2013Philips 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
JAKNone listed
Mar 13, 2013Philips 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
JAKNone listed
Jul 19, 2012Philips 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
JAKNone listed
Jul 12, 2012Philips 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
JAKNone listed
Jul 11, 2012Philips 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
JAKNone listed
Jul 11, 2012Philips 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
JAKNone listed
Jun 8, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
May 30, 2012Philips 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
JAKNone listed
Mar 30, 2012Philips 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
KPSNone listed
Jan 24, 2012Philips 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
JAKNone listed
Sep 14, 2011Philips 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
JAKNone listed
Sep 14, 2011Philips 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
JAKNone listed
May 19, 2011Philips 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
JAKNone listed
Mar 16, 2011Philips 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
KPSNone listed
Sep 22, 2010Philips 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
JAKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.