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) |
|---|---|---|---|
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | K031469 |
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | K050458 |
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | K072606 |
| Sep 13, 2011 | Toshiba American Medical Systems Inc TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed
X-Ray Tomography Terminated |
JAK | K083282 |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with so Terminated |
JAK | K052640 |
| Sep 13, 2011 | Philips Medical Systems (Cleveland) Inc Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped wi Terminated |
JAK | K052640 |
| Aug 12, 2011 | Imaging Sciences International, LLC i-CAT Classic (X-Ray Tube head and Power Supply)
X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a de Terminated |
JAK | K051980 |
| Jul 29, 2011 | Toshiba American Medical Systems Inc Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography.
Toshiba American Medical Systems, Inc.
A multislice CT system that supports whole-body scanning. Terminated |
JAK | K083282 |
| Jul 29, 2011 | Toshiba American Medical Systems Inc Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography.
Toshiba American Medical Systems, Inc.
A multislice CT system that supports whole-body scanning. Terminated |
JAK | K083282 |
| Jul 9, 2011 | Philips Medical Systems North America Co. Phillips The SIU (System Interface Unit) is a component in the Tool Connection Unit of the PercuNav system. It is part of the position sensor system used to calculate the position of the instrument.
The Tool Terminated |
JAK | K053610 |
| May 23, 2011 | 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 |
| May 19, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030.
Intended to produce cross-sectional imag Terminated |
JAK | K033357 |
| May 19, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance 64, Computed Tomography X-Ray System, Model Numbers: 728231 and 728326, including the Ingenuity CT. The recalled units are equipped with software versions: 3.5.21028 and 3.5.25028.
Inten Terminated |
JAK | K033326 |
| 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 | K060937 |
| May 19, 2011 | Philips Medical Systems North America Co. Phillips PercuNav Field Generator Stand is a Computed tomography, X-Ray System. Part Number 453561431911.
Designed to be used only with the PercuNav" image guided intervention system. The Field Generator St Terminated |
JAK | K053610 |
| May 19, 2011 | GE Healthcare, LLC BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4.
The GE BrightSpeed Del Terminated |
JAK | K082816 |
| May 19, 2011 | Toshiba American Medical Systems Inc CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed Terminated |
JAK | K080211 |
| Apr 26, 2011 | Philips Medical Systems (Cleveland) Inc MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371.
The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system f Terminated |
JAK | K083498 K091195 |
| Mar 24, 2011 | Philips Medical Systems (Cleveland) Inc Brilliance 64 S/N 9089, 9551, 9548.
The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission da Terminated |
JAK | K033326 |
| Mar 16, 2011 | Toshiba American Medical Systems Inc TSX-301A: AQUILION ONE System
AQUILION ONE is a multislice CT system that supports whole body scanning. The system supports simultaneous data acquisitions of 320 slices using the Selectable Slice-thi Terminated |
JAK | K083282 |
| Mar 4, 2011 | Philips Medical Systems Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8
Philips Medical Systems
An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomo Terminated |
JAK | K041218 |
| Mar 4, 2011 | Philips Medical Systems Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8;
Philips Medical Systems
An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed t Terminated |
JAK | K041218 |
| Mar 1, 2011 | GE Healthcare, LLC BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System.
For head, whole body X-ray Computed Tomography applications. Terminated |
JAK | None listed |
| Feb 15, 2011 | Toshiba American Medical Systems Inc Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner Terminated |
JAK | K083282 |
| Feb 7, 2011 | GE Healthcare, LLC GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010.
Head a Terminated |
JAK | None listed |
| Feb 7, 2011 | GE Healthcare, LLC GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August Terminated |
JAK | None listed |
| Feb 7, 2011 | GE Healthcare, LLC GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010.
Head and whole Terminated |
JAK | None listed |
| Feb 7, 2011 | GE Healthcare, LLC GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010.
Head and whole bo Terminated |
JAK | None listed |
| Feb 7, 2011 | GE Healthcare, LLC LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to A Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2249696) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2201000) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2201000-2 with Gantry mo. #2200997) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2249696) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2201000) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997-2 with Gantry mo. #2200997) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2249696-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2249696) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2201000-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2200997-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2201000) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed FX/I (2200997 with Gantry mo. #2200997) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC Hi Speed DX/I (2249696-2) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed DX/I (2249696) Terminated |
JAK | None listed |
| Jan 4, 2011 | GE Healthcare, LLC HiSpeed DX/I (2201000-2) Terminated |
JAK | None listed |
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