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) |
|---|---|---|---|
| Jun 4, 2019 | Siemens 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 |
JAK | K173632 |
| Jun 4, 2019 | Siemens 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 |
JAK | K173632 |
| May 28, 2019 | Siemens 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 |
JAK | K173632 |
| May 28, 2019 | Siemens 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 |
JAK | K173632 |
| May 28, 2019 | Siemens 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 |
JAK | K173632 |
| May 28, 2019 | Siemens 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 |
JAK | K173632 |
| Mar 21, 2019 | Siemens 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 |
JAK | K170221 |
| Mar 21, 2019 | Siemens 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 |
JAK | K110366 |
| Mar 20, 2019 | GE 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 |
JAK | K121019 |
| Mar 20, 2019 | GE 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 |
JAK | K093514 |
| Mar 20, 2019 | GE 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 |
JAK | K153402 |
| Mar 20, 2019 | GE 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 |
JAK | K173816 |
| Mar 20, 2019 | GE 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 |
JAK | K173816 |
| Mar 20, 2019 | GE 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 |
JAK | K173816 |
| Mar 20, 2019 | GE 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 |
JAK | K093514 |
| Mar 20, 2019 | GE 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 |
JAK | K093514 |
| Mar 20, 2019 | GE 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 |
JAK | K153402 |
| Mar 20, 2019 | GE 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 |
JAK | K111445 |
| Mar 19, 2019 | Carestream 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 |
JAK | K173478 |
| Feb 14, 2019 | Siemens 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 |
JAK | K103127 |
| Feb 14, 2019 | Siemens 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 |
JAK | K173607 |
| Feb 14, 2019 | Siemens 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 |
JAK | K173630 |
| Feb 14, 2019 | Siemens 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 |
JAK | K173630 |
| Feb 6, 2019 | GE 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 |
JAK | K133705 K163213 |
| Jan 19, 2019 | GE 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 |
JAK | K133705 K163213 |
| Jan 9, 2019 | NEUSOFT 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 |
JAK | K151383 |
| Oct 22, 2018 | Neusoft 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 |
JAK | K171198 |
| Oct 22, 2018 | Neusoft 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 |
JAK | K151383 |
| Oct 22, 2018 | Neusoft 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 |
JAK | K121792 |
| Oct 18, 2018 | Philips 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 |
JAK | K012009 |
| Oct 18, 2018 | Philips 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 |
JAK | K012009 |
| Oct 18, 2018 | Philips 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 |
JAK | K012009 |
| Oct 18, 2018 | Philips 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 |
JAK | K012009 |
| Oct 18, 2018 | Philips 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 |
JAK | K033326 |
| Oct 18, 2018 | Philips 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 |
JAK | K033326 |
| Aug 1, 2018 | Mobius Imaging, LLC AIRO Mobile CT System
Model # MobiCT-32 Terminated |
JAK | K180393 |
| Jul 3, 2018 | Philips 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 |
JAK | K162838 |
| Jul 3, 2018 | Philips 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 |
JAK | K033326 |
| Jul 3, 2018 | Philips 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 |
JAK | K012009 |
| Jun 29, 2018 | Hitachi 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 |
JAK | K150595 |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765 Terminated |
JAK | K934206 |
| Jun 28, 2018 | Bayer Medical Care, Inc. Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 Terminated |
JAK | K944983 |
| Jun 28, 2018 | Bayer 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 |
JAK | K944983 |
| Jun 8, 2018 | Siemens 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 |
JAK | K173578 |
| May 24, 2018 | GE Healthcare, LLC CT Goldseal BrightSpeed 16 PWR TIO 2 YR Terminated |
JAK | K052855 |
| May 24, 2018 | GE Healthcare, LLC Optima CT 540 Terminated |
JAK | K082816 |
| May 24, 2018 | GE Healthcare, LLC Optima CT 520 Terminated |
JAK | K123596 |
| May 24, 2018 | GE Healthcare, LLC Revolution EVO 3.6, labeled as
a. HVY WAUK;
b. LONG HINO;
c. LONG WAUK;
d. MID BJG;
e. MID WAUK. Terminated |
JAK | K131576 |
| May 24, 2018 | GE Healthcare, LLC CT Goldseal Optima CT 600 Terminated |
JAK | K110227 K131576 |
| May 24, 2018 | GE Healthcare, LLC Revolution CT 160 1.5D STD WAUK Terminated |
JAK | K133705 K163213 |
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