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Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Mar 1, 2013GE Healthcare, LLC
GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation
Terminated
JAKK041521
K972399
Feb 28, 2013Philips Medical Systems (Cleveland) Inc
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
Terminated
JAKK083498
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
Terminated
JAKK012009
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Terminated
JAKK033357
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice
Terminated
JAKNone listed
Jan 16, 2013Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-
Terminated
JAKK961464
Jan 15, 2013Philips 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
JAKK033326
Dec 4, 2012Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body compute
Terminated
JAKK062451
K071308 +2
Sep 27, 2012Toshiba American Medical Systems Inc
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and periphe
Terminated
JAKK072606
Sep 25, 2012Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed
Terminated
JAKK012009
K013521
Sep 19, 2012Philips Medical Systems (Cleveland) Inc
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ra
Terminated
JAKK012009
Sep 14, 2012Philips Medical Systems (Cleveland) Inc
MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
Terminated
JAKK083498
K091195
Aug 28, 2012Toshiba American Medical Systems Inc
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
Terminated
JAKK072606
Aug 24, 2012Toshiba American Medical Systems Inc
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is des
Terminated
JAKNone listed
Aug 22, 2012Philips 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
JAKK012009
K033326 +1
Aug 17, 2012Philips Medical Systems (Cleveland) Inc
The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken a
Terminated
JAKK033326
Jul 26, 2012Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM*
Terminated
JAKK090173
K092742
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
JAKK012009
K033326 +2
Jul 19, 2012Hitachi Medical Systems America Inc
Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical
Terminated
JAKK101888
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
JAKK012009
K033326 +1
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
JAKK012009
K033326 +1
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
JAKK012009
K033326 +1
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
JAKK060937
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
JAKK060937
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
JAKK012009
K033326 +2
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
JAKK012009
K033326 +2
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
JAKK012009
K033326 +2
May 30, 2012Philips Medical Systems (Cleveland) Inc
Brilliance 16 - Model #728246, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big Bore, iCT, iCT SP and Ingenuity CT are Computed Tomography X-Ray Syst
Terminated
JAKK012009
Apr 5, 2012Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workstation Computed Tomography X-Ray Systems, M/N 728260, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intende
Terminated
JAKNone listed
Apr 5, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray Systems are intended to
Terminated
JAKNone listed
Apr 2, 2012Philips Medical Systems (Cleveland) Inc
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model# 728231, Ingenuity CT Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and In
Terminated
JAKK033326
Mar 23, 2012Philips Medical Systems (Cleveland) Inc
Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance 64 M/N 728231, Ingenuity CT M/N 728326, Dist. By Philips Medical Systems, Cleveland, OH
Terminated
JAKK033326
Feb 16, 2012Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, 300005, and 300010. Product Usage: The Ingenuity CT is a Computed Tomography X-Ray System
Terminated
JAKK033326
Feb 15, 2012Toshiba American Medical Systems Inc
TSX-301B: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 207
Terminated
JAKK083282
Feb 15, 2012Toshiba American Medical Systems Inc
TSX-301A: AQUILION ONE; System, X-Ray, Tomography, Computed Last four of Serial Number: 2005, 2008, 2010, 2023, 2026, 2034, 2036, 2038, 2048, 2049, 2051, 2052, 2053, 2061, 2063, 2067, 2070, 2071, 207
Terminated
JAKK083282
Feb 3, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes.
Terminated
JAKK033357
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
JAKK033326
K033357 +1
Jan 17, 2012Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300003, 300004, and 300005. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Produc
Terminated
JAKK033326
Jan 17, 2012Philips Medical Systems (Cleveland) Inc
Brilliance 64 CT (Computed Tomography) System, 510 (k) #K033326, Model #728231, Serial Numbers: 4003, 9875, and 90135. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product
Terminated
JAKK033326
Jan 17, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Pro
Terminated
JAKK033357
Jan 11, 2012Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Computed Tomography) System, 510 (k) #K033326, Model #728326, Serial Numbers: 300005, 300010, 300011, 300012, 300013, 300014, 300015, 300016, 300017, 300018, 300019, 300020 and 300021.
Terminated
JAKK033326
Dec 2, 2011Philips Medical Systems (Cleveland) Inc
Ingenuity CT computed Tomography System, Model #728326, 510(k) #K 033326, Serial Numbers: 300010 and 300018. The Ingenuity CT is a Computed Tomography X-Ray System intended to produce cross-sectiona
Terminated
JAKK033326
Dec 2, 2011Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography System, Model #728231, 510(k) #K 033326, Serial Numbers: 95504, 91003, 300030, 95130, and 95157. The Brilliance 64 is a Computed Tomography X-Ray System intended to
Terminated
JAKK033326
Dec 1, 2011Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231, Serial Numbers: 9745, 90169, and 95414. The recalled device systems are equipped with Version 3.5 Beta 1 softwa
Terminated
JAKK033326
Dec 1, 2011Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 softwar
Terminated
JAKK033357
Nov 23, 2011Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System.
Terminated
JAKK082506
Sep 27, 2011Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography System, Model #78231, Serial Number: 9592. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by compute
Terminated
JAKK033326
Sep 16, 2011Toshiba American Medical Systems Inc
TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
Terminated
JAKK080211
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
JAKK060937
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
JAKK060937

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