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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)
Jun 4, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional image
Terminated
JAKK173632
Jun 4, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images
Terminated
JAKK173632
May 28, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images
Terminated
JAKK173632
May 28, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images
Terminated
JAKK173632
May 28, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images
Terminated
JAKK173632
May 28, 2019Siemens Medical Solutions USA, Inc
SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of
Terminated
JAKK173632
Mar 21, 2019Siemens Medical Solutions USA, Inc
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angio
Terminated
JAKK170221
Mar 21, 2019Siemens Medical Solutions USA, Inc
syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angio
Terminated
JAKK110366
Mar 20, 2019GE Healthcare, LLC
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includ
Terminated
JAKK121019
Mar 20, 2019GE Healthcare, LLC
NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases
Terminated
JAKK093514
Mar 20, 2019GE Healthcare, LLC
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer up
Terminated
JAKK153402
Mar 20, 2019GE Healthcare, LLC
NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general
Terminated
JAKK173816
Mar 20, 2019GE Healthcare, LLC
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general pu
Terminated
JAKK173816
Mar 20, 2019GE Healthcare, LLC
NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake
Terminated
JAKK173816
Mar 20, 2019GE Healthcare, LLC
Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of
Terminated
JAKK093514
Mar 20, 2019GE Healthcare, LLC
Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing o
Terminated
JAKK093514
Mar 20, 2019GE Healthcare, LLC
Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tr
Terminated
JAKK153402
Mar 20, 2019GE Healthcare, LLC
Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope trac
Terminated
JAKK111445
Mar 19, 2019Carestream Health, Inc.
OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) The device is intended to be used for x-ray computed tomograp
Terminated
JAKK173478
Feb 14, 2019Siemens Medical Solutions USA, Inc
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process
Terminated
JAKK103127
Feb 14, 2019Siemens Medical Solutions USA, Inc
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissio
Terminated
JAKK173607
Feb 14, 2019Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray trans
Terminated
JAKK173630
Feb 14, 2019Siemens Medical Solutions USA, Inc
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmissi
Terminated
JAKK173630
Feb 6, 2019GE Healthcare, LLC
Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Open, Classified
JAKK133705
K163213
Jan 19, 2019GE Healthcare, LLC
Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Open, Classified
JAKK133705
K163213
Jan 9, 2019NEUSOFT MEDICAL SYSTEMS IMP & EX
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a
Terminated
JAKK151383
Oct 22, 2018Neusoft Medical Systems Co., Ltd.
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray t
Terminated
JAKK171198
Oct 22, 2018Neusoft Medical Systems Co., Ltd.
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and
Terminated
JAKK151383
Oct 22, 2018Neusoft Medical Systems Co., Ltd.
NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube and
Terminated
JAKK121792
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data ta
Terminated
JAKK012009
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t
Terminated
JAKK012009
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data t
Terminated
JAKK012009
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data
Terminated
JAKK012009
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at diff
Terminated
JAKK033326
Oct 18, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at dif
Terminated
JAKK033326
Aug 1, 2018Mobius Imaging, LLC
AIRO Mobile CT System Model # MobiCT-32
Terminated
JAKK180393
Jul 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance iCT, 728306 Product Usage: 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
Terminated
JAKK162838
Jul 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 64, 728231 Product Usage: 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
Terminated
JAKK033326
Jul 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at differ
Terminated
JAKK012009
Jun 29, 2018Hitachi Medical Systems America Inc
Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can
Terminated
JAKK150595
Jun 28, 2018Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
Terminated
JAKK934206
Jun 28, 2018Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
Terminated
JAKK944983
Jun 28, 2018Bayer Medical Care, Inc.
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material N
Terminated
JAKK944983
Jun 8, 2018Siemens Medical Solutions USA, Inc.
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positro
Terminated
JAKK173578
May 24, 2018GE Healthcare, LLC
CT Goldseal BrightSpeed 16 PWR TIO 2 YR
Terminated
JAKK052855
May 24, 2018GE Healthcare, LLC
Optima CT 540
Terminated
JAKK082816
May 24, 2018GE Healthcare, LLC
Optima CT 520
Terminated
JAKK123596
May 24, 2018GE Healthcare, LLC
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Terminated
JAKK131576
May 24, 2018GE Healthcare, LLC
CT Goldseal Optima CT 600
Terminated
JAKK110227
K131576
May 24, 2018GE Healthcare, LLC
Revolution CT 160 1.5D STD WAUK
Terminated
JAKK133705
K163213

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