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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)
May 24, 2018GE Healthcare, LLC
Discovery RT labeled as: a. MID BJG; b. HVY BJG
Terminated
JAKK132410
Apr 27, 2018GE Healthcare Japan Corporation
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names:
Terminated
JAKK082816
K110227 +1
Apr 27, 2018GE Healthcare Japan Corporation
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540,
Terminated
JAKK082816
Apr 27, 2018GE Healthcare Japan Corporation
GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIM
Terminated
JAKK110227
Apr 27, 2018GE Healthcare Japan Corporation
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the foll
Terminated
JAKK131576
Apr 20, 2018Siemens Medical Solutions USA, Inc
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Terminated
JAKK163296
Apr 20, 2018Siemens Medical Solutions USA, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
Terminated
JAKK163296
Mar 30, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Terminated
JAKK012009
Mar 30, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Terminated
JAKK012009
Mar 30, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
Terminated
JAKK033326
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Spirit(Model 10045692 )
Terminated
JAKNone listed
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Scope Power (Model 10967888)
Terminated
JAKK140912
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Scope ( Model 10967666)
Terminated
JAKK140912
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Perspective 16 (Model 10891666)
Terminated
JAKK113287
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Perspective (Model 10495568)
Terminated
JAKK113287
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion 16 (10165977)
Terminated
JAKK023687
Mar 30, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion 6 (Model 10165888)
Terminated
JAKK023687
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity Core128/Elite China 728324
Terminated
JAKK160743
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity Core128 728323
Terminated
JAKK160743
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Philips Ingenuity Core 728321
Terminated
JAKK160743
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology 728244
Terminated
JAKK033357
Feb 21, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction
Terminated
JAKK033326
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK050297
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK050297
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK050297
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK050297
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK042328
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK151765
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 15, 2018Siemens Medical Solutions USA, Inc
SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Terminated
JAKK142955
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon
Terminated
JAKK012009
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
IQon Spectral CT - Model no. 728332, 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
JAKK133674
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 64 - Model no. 728231, 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
JAKK033326
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reco
Terminated
JAKK012009
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute
Terminated
JAKK033357
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer
Terminated
JAKK033357
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
JAKK060937
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
JAKK060937
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer rec
Terminated
JAKK033326
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity Core - Model no. 728321, 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
JAKK033326
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstru
Terminated
JAKK033326
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction
Terminated
JAKK033326
Jan 26, 2018Siemens Medical Solutions USA, Inc.
Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
Terminated
JAKK170904

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