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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)
Nov 19, 2021Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
Open, Classified
JAKK190578
Nov 19, 2021Siemens Medical Solutions USA, Inc
SOMATOM Edge Plus-Computed tomography system Model 1026700
Open, Classified
JAKK190578
Nov 19, 2021Siemens Medical Solutions USA, Inc
SOMATOM Definition AS-Computed tomography system Model 8098027
Open, Classified
JAKK190578
Nov 19, 2021Siemens Medical Solutions USA, Inc
SOMATOM Confidence -Computed tomography systems Model 10590100
Open, Classified
JAKK190578
Sep 10, 2021Siemens 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
JAKK200524
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Drive with software syngo.CT VB20 Model #10431700
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Terminated
JAKK190578
Aug 30, 2021Siemens Medical Solutions USA, Inc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Terminated
JAKK190578
Aug 18, 2021Siemens 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
JAKK200524
Jul 8, 2021GE Healthcare, LLC
Revolution CT
Completed
JAKK133705
K163213 +1
Jun 30, 2021GE 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
JAKK203169
Jun 30, 2021GE 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
JAKK163213
K191777
Jun 30, 2021GE 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
JAKK133705
K163213 +1
Jun 14, 2021GE Healthcare, LLC
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Open, Classified
JAKK131576
Jun 8, 2021Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Terminated
JAKK203020
Jun 8, 2021Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Terminated
JAKK193454
Jun 8, 2021Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Terminated
JAKK160743
Jun 8, 2021Philips North America Llc
Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system
Terminated
JAKK160743
Jun 8, 2021Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Terminated
JAKK162838
May 1, 2021Philips 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
JAKK001088
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
Open, Classified
JAKK060937
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
Open, Classified
JAKK052640
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:
Open, Classified
JAKK203020
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Open, Classified
JAKK193454
May 1, 2021Philips 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
JAKK160743
May 1, 2021Philips 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
JAKK033357
May 1, 2021Philips 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
JAKK033326
May 1, 2021Philips 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
JAKK012009
May 1, 2021Philips 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
JAKK091195
May 1, 2021Philips 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
JAKK010817
Apr 13, 2021Philips 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
JAKK060937
Mar 3, 2021Siemens 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
JAKK163296
K173632 +2
Feb 24, 2021Philips 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
JAKK180015
Feb 22, 2021Philips North America Llc
Incisive CT Computed Tomography X-ray System Model: 728143
Terminated
JAKK180015
Feb 11, 2021Imactis
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Terminated
JAKK162314
Dec 17, 2020GE Healthcare, LLC
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Terminated
JAKK133705
K163213 +1
Dec 17, 2020GE Healthcare, LLC
System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition
Terminated
JAKK163213
K191777
Nov 24, 2020Siemens Medical Solutions USA, Inc
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
Terminated
JAKK103127
K121072 +4
Nov 23, 2020GE 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
JAKK191777
Nov 23, 2020GE Healthcare, LLC
Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
Terminated
JAKK191777
Nov 9, 2020Canon 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
JAKK192832
Sep 28, 2020Siemens 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
JAKK103127
K121072 +4
Sep 21, 2020GE 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
JAKK191777
Aug 24, 2020Imactis
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)
Open, Classified
JAKK162314
Aug 13, 2020Shanghai 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
JAKK182237
Aug 5, 2020Shanghai 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
JAKK172135

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