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)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2013 | GE 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 |
JAK | K041521 K972399 |
| Feb 28, 2013 | Philips Medical Systems (Cleveland) Inc Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. Terminated |
JAK | K083498 |
| Feb 26, 2013 | Philips 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 |
JAK | K012009 |
| Feb 26, 2013 | Philips 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 |
JAK | K033357 |
| Feb 26, 2013 | Philips 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 |
JAK | None listed |
| Jan 16, 2013 | Philips 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 |
JAK | K961464 |
| 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 | K033326 |
| Dec 4, 2012 | Philips 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 |
JAK | K062451 K071308 +2 |
| Sep 27, 2012 | Toshiba 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 |
JAK | K072606 |
| Sep 25, 2012 | Philips 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 |
JAK | K012009 K013521 |
| Sep 19, 2012 | Philips 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 |
JAK | K012009 |
| Sep 14, 2012 | Philips 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 |
JAK | K083498 K091195 |
| Aug 28, 2012 | Toshiba 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 |
JAK | K072606 |
| Aug 24, 2012 | Toshiba 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 |
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 | K012009 K033326 +1 |
| Aug 17, 2012 | Philips 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 |
JAK | K033326 |
| Jul 26, 2012 | Philips 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 |
JAK | K090173 K092742 |
| 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 | K012009 K033326 +2 |
| Jul 19, 2012 | Hitachi 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 |
JAK | K101888 |
| 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 | K012009 K033326 +1 |
| 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 | K012009 K033326 +1 |
| 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 | K012009 K033326 +1 |
| 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 | K060937 |
| 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 | K060937 |
| 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 | K012009 K033326 +2 |
| 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 | K012009 K033326 +2 |
| 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 | K012009 K033326 +2 |
| May 30, 2012 | Philips 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 |
JAK | K012009 |
| Apr 5, 2012 | Philips 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 |
JAK | None listed |
| Apr 5, 2012 | Philips 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 |
JAK | None listed |
| Apr 2, 2012 | Philips 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 |
JAK | K033326 |
| Mar 23, 2012 | Philips 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 |
JAK | K033326 |
| Feb 16, 2012 | Philips 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 |
JAK | K033326 |
| Feb 15, 2012 | Toshiba 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 |
JAK | K083282 |
| Feb 15, 2012 | Toshiba 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 |
JAK | K083282 |
| Feb 3, 2012 | Philips 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 |
JAK | K033357 |
| 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 | K033326 K033357 +1 |
| Jan 17, 2012 | Philips 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 |
JAK | K033326 |
| Jan 17, 2012 | Philips 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 |
JAK | K033326 |
| Jan 17, 2012 | Philips 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 |
JAK | K033357 |
| Jan 11, 2012 | Philips 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 |
JAK | K033326 |
| Dec 2, 2011 | Philips 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 |
JAK | K033326 |
| Dec 2, 2011 | Philips 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 |
JAK | K033326 |
| Dec 1, 2011 | Philips 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 |
JAK | K033326 |
| Dec 1, 2011 | Philips 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 |
JAK | K033357 |
| Nov 23, 2011 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System. Terminated |
JAK | K082506 |
| Sep 27, 2011 | Philips 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 |
JAK | K033326 |
| Sep 16, 2011 | Toshiba American Medical Systems Inc TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed. Terminated |
JAK | K080211 |
| 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 | K060937 |
| 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 | K060937 |
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