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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)
Sep 13, 2011Toshiba American Medical Systems Inc
TSX-101A: AQUILION 16; System, X-Ray, Tomography, Computed X-Ray Tomography
Terminated
JAKK031469
Sep 13, 2011Toshiba American Medical Systems Inc
TSX-201A: AQUlLlON LB; System, X-Ray, Tomography, Computed X-Ray Tomography
Terminated
JAKK050458
Sep 13, 2011Toshiba American Medical Systems Inc
TSX-301A: AQUILION One; System, X-Ray, Tomography, Computed X-Ray Tomography
Terminated
JAKK072606
Sep 13, 2011Toshiba American Medical Systems Inc
TSX-301B: AQUILION Premium; System, X-Ray, Tomography, Computed X-Ray Tomography
Terminated
JAKK083282
Sep 13, 2011Philips 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
JAKK052640
Sep 13, 2011Philips 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
JAKK052640
Aug 12, 2011Imaging 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
JAKK051980
Jul 29, 2011Toshiba 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
JAKK083282
Jul 29, 2011Toshiba 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
JAKK083282
Jul 9, 2011Philips 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
JAKK053610
May 23, 2011Philips 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
May 19, 2011Philips 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
JAKK033357
May 19, 2011Philips 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
JAKK033326
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
JAKK060937
May 19, 2011Philips 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
JAKK053610
May 19, 2011GE 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
JAKK082816
May 19, 2011Toshiba American Medical Systems Inc
CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System, X-Ray, Tomography Computed
Terminated
JAKK080211
Apr 26, 2011Philips 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
JAKK083498
K091195
Mar 24, 2011Philips 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
JAKK033326
Mar 16, 2011Toshiba 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
JAKK083282
Mar 4, 2011Philips 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
JAKK041218
Mar 4, 2011Philips 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
JAKK041218
Mar 1, 2011GE Healthcare, LLC
BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications.
Terminated
JAKNone listed
Feb 15, 2011Toshiba American Medical Systems Inc
Toshiba TSX-301A AQUILION ONE (MPDCT0297EA) - Whole Body X-Ray CT Scanner
Terminated
JAKK083282
Feb 7, 2011GE 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
JAKNone listed
Feb 7, 2011GE 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
JAKNone listed
Feb 7, 2011GE 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
JAKNone listed
Feb 7, 2011GE 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
JAKNone listed
Feb 7, 2011GE 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
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2249696)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2201000)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2201000-2 with Gantry mo. #2200997)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2201000)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2249696-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2249696)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2201000-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2200997-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2201000)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed FX/I (2200997 with Gantry mo. #2200997)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
Hi Speed DX/I (2249696-2)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed DX/I (2249696)
Terminated
JAKNone listed
Jan 4, 2011GE Healthcare, LLC
HiSpeed DX/I (2201000-2)
Terminated
JAKNone listed

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