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) |
|---|---|---|---|
| May 24, 2018 | GE Healthcare, LLC Discovery RT labeled as:
a. MID BJG;
b. HVY BJG Terminated |
JAK | K132410 |
| Apr 27, 2018 | GE 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 |
JAK | K082816 K110227 +1 |
| Apr 27, 2018 | GE 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 |
JAK | K082816 |
| Apr 27, 2018 | GE 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 |
JAK | K110227 |
| Apr 27, 2018 | GE 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 |
JAK | K131576 |
| Apr 20, 2018 | Siemens 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 |
JAK | K163296 |
| Apr 20, 2018 | Siemens 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 |
JAK | K163296 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system Terminated |
JAK | K012009 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system Terminated |
JAK | K012009 |
| Mar 30, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Spirit(Model 10045692 ) Terminated |
JAK | None listed |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Scope Power (Model 10967888) Terminated |
JAK | K140912 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Scope ( Model 10967666) Terminated |
JAK | K140912 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Perspective 16 (Model 10891666) Terminated |
JAK | K113287 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Perspective (Model 10495568) Terminated |
JAK | K113287 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 16 (10165977) Terminated |
JAK | K023687 |
| Mar 30, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Emotion 6 (Model 10165888) Terminated |
JAK | K023687 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128/Elite China 728324 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128 728323 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core 728321 Terminated |
JAK | K160743 |
| Mar 28, 2018 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore Radiology 728244 Terminated |
JAK | K033357 |
| Feb 21, 2018 | Philips 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 |
JAK | K033326 |
| Feb 15, 2018 | Siemens 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 |
JAK | K050297 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K050297 |
| Feb 15, 2018 | Siemens 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 |
JAK | K050297 |
| Feb 15, 2018 | Siemens 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 |
JAK | K050297 |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Spirit
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | K042328 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Scope
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K151765 |
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Perspective
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 15, 2018 | Siemens 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 |
JAK | K142955 |
| Feb 8, 2018 | Philips 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 |
JAK | K012009 |
| Feb 8, 2018 | Philips 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 |
JAK | K133674 |
| Feb 8, 2018 | Philips 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 |
JAK | K033326 |
| Feb 8, 2018 | Philips 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 |
JAK | K012009 |
| Feb 8, 2018 | Philips 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 |
JAK | K033357 |
| Feb 8, 2018 | Philips 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 |
JAK | K033357 |
| Feb 8, 2018 | Philips 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 |
JAK | K060937 |
| Feb 8, 2018 | Philips 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 |
JAK | K060937 |
| Feb 8, 2018 | Philips 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 |
JAK | K033326 |
| Feb 8, 2018 | Philips 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 |
JAK | K033326 |
| Feb 8, 2018 | Philips 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 |
JAK | K033326 |
| Feb 8, 2018 | Philips 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 |
JAK | K033326 |
| Jan 26, 2018 | Siemens Medical Solutions USA, Inc. Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner. Terminated |
JAK | K170904 |
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