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) |
|---|---|---|---|
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge -Computed tomography system
Model 10590000 Open, Classified |
JAK | K190578 |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus-Computed tomography system
Model 1026700 Open, Classified |
JAK | K190578 |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS-Computed tomography system
Model 8098027 Open, Classified |
JAK | K190578 |
| Nov 19, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Confidence -Computed tomography systems
Model 10590100 Open, Classified |
JAK | K190578 |
| Sep 10, 2021 | Siemens Medical Solutions USA, Inc syngo.CT VA20A, VA30A and VA40A in:
syngo.via RT Image Suite / Sim&Go
SOMATOM go.Now
SOMATOM go.Up
SOMATOM go.All
SOMATOM go.Top
SOMATOM go.Sim
SOMATOM go.Open Pro and
SOMATOM X.cite
Material Open, Classified |
JAK | K200524 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Edge Plus with software syngo.CT VB20
Model #10267000 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Confidence with software syngo.CT VB20
Model #10590100 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Drive with software syngo.CT VB20
Model #10431700 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash with software syngo.CT VB20
Model #10430603 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge with software syngo.CT VB20
Model #10590000 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS with software syngo.CT VB20
Model #8098027 Terminated |
JAK | K190578 |
| Aug 30, 2021 | Siemens Medical Solutions USA, Inc SOMATOM Force with software syngo.CT VB20
Model #10742326 Terminated |
JAK | K190578 |
| Aug 18, 2021 | Siemens Medical Solutions USA, Inc Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems:
SOMATOM go.Up - Model 11061620
SOMATOM go.Up - Model 1106 Open, Classified |
JAK | K200524 |
| Jul 8, 2021 | GE Healthcare, LLC Revolution CT Completed |
JAK | K133705 K163213 +1 |
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumet Open, Classified |
JAK | K203169 |
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system ha Open, Classified |
JAK | K163213 K191777 |
| Jun 30, 2021 | GE Healthcare, LLC The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system ha Open, Classified |
JAK | K133705 K163213 +1 |
| Jun 14, 2021 | GE Healthcare, LLC Revolution EVO, Optima CT660, Optima CT680 CT Systems. Open, Classified |
JAK | K131576 |
| Jun 8, 2021 | Philips North America Llc 728333 Spectral CT 7500 -Computed Tomography X-ray system Terminated |
JAK | K203020 |
| Jun 8, 2021 | Philips North America Llc 728332 IQon Spectral CT-Computed Tomography X-ray system Terminated |
JAK | K193454 |
| Jun 8, 2021 | Philips North America Llc 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system Terminated |
JAK | K160743 |
| Jun 8, 2021 | Philips North America Llc Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system Terminated |
JAK | K160743 |
| Jun 8, 2021 | Philips North America Llc 728306 Brilliance iCT-Computed Tomography X-ray systems
728305 Brilliance iCT Upgrades Terminated |
JAK | K162838 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT
System Number: 728209
Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologi Open, Classified |
JAK | K001088 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728306 - Brilliance iCT
728311 - Brilliance iCT SP Open, Classified |
JAK | K060937 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
882442/882456 - Ingenuity TF PET/CT Open, Classified |
JAK | K052640 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728333 - Spectral CT: Open, Classified |
JAK | K203020 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
728332 - IQon Spectral CT
: IQon Spectral CT Open, Classified |
JAK | K193454 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor
Ingenuity Core, Ingenuity Core 128, Ingenuity CT
728321 - Ingenuity Core
728323 - Ingenuity Core 128
728326/728327 - Ingenu Open, Classified |
JAK | K160743 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
BB (Big Bore) Oncology, BB (Big Bore) Radiology:
728242/728243/728244 Open, Classified |
JAK | K033357 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
Brilliance 64, Brilliance 40, Ingenuity Flex
728235 - Brilliance 40
728 Open, Classified |
JAK | K033326 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems.
Brilliance 16 Power, Brilliance 16/10/6 Water/Air
728240/728245/728246 Open, Classified |
JAK | K012009 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16
Models: 728131 Open, Classified |
JAK | K091195 |
| May 1, 2021 | Philips North America Llc Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems:
Model - MX8000
Models: 728120/728125/728201 Open, Classified |
JAK | K010817 |
| Apr 13, 2021 | Philips North America Llc BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body.
Model Number: 728306 Terminated |
JAK | K060937 |
| Mar 3, 2021 | Siemens Medical Solutions USA, Inc Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows:
SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628)
SOMATOM go.All (Mo Terminated |
JAK | K163296 K173632 +2 |
| Feb 24, 2021 | Philips Healthcare (Suzhou) Co., Ltd. Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and wh Terminated |
JAK | K180015 |
| Feb 22, 2021 | Philips North America Llc Incisive CT Computed Tomography X-ray System
Model: 728143 Terminated |
JAK | K180015 |
| Feb 11, 2021 | Imactis Impactis NaviKit-stereotaxic accessory for Computed Tomography systems
Reference # I10100 Terminated |
JAK | K162314 |
| Dec 17, 2020 | GE Healthcare, LLC System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES. Terminated |
JAK | K133705 K163213 +1 |
| Dec 17, 2020 | GE Healthcare, LLC System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition Terminated |
JAK | K163213 K191777 |
| Nov 24, 2020 | Siemens Medical Solutions USA, Inc SOMATOM Force, Definition AS, Definition Edge, Definition Flash,
Drive, Confidence and Edge Plus Terminated |
JAK | K103127 K121072 +4 |
| Nov 23, 2020 | GE Healthcare, LLC Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Terminated |
JAK | K191777 |
| Nov 23, 2020 | GE Healthcare, LLC Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Terminated |
JAK | K191777 |
| Nov 9, 2020 | Canon Medical System, USA, INC. Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Terminated |
JAK | K192832 |
| Sep 28, 2020 | Siemens Medical Solutions USA, Inc Software versions syngo.CT VB20 or VB20_SP1 in the following systems:
SOMATOM Force (Model #10742326)
SOMATOM Definition As (Model #8098027)
SOMATOM Definition Edge (Model #10590000)
SOMATOM Definitio Terminated |
JAK | K103127 K121072 +4 |
| Sep 21, 2020 | GE Healthcare, LLC Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Terminated |
JAK | K191777 |
| Aug 24, 2020 | Imactis Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180) Open, Classified |
JAK | K162314 |
| Aug 13, 2020 | Shanghai United Imaging Healthcare Co., Ltd. uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, res Terminated |
JAK | K182237 |
| Aug 5, 2020 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Open, Classified |
JAK | K172135 |
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