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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)
Jan 11, 2018Philips Medical Systems (Cleveland) Inc
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Terminated
JAKK133674
Jan 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons
Terminated
JAKK033357
Jan 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon
Terminated
JAKK033357
Dec 11, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) syste
Terminated
JAKK172406
Nov 10, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Terminated
JAKK160743
Nov 10, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Terminated
JAKK160743
Nov 10, 2017Philips Medical Systems (Cleveland) Inc
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Terminated
JAKK033326
Nov 10, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Terminated
JAKK162838
Nov 8, 2017Siemens Medical Solutions USA, Inc
SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system
Terminated
JAKK142955
Nov 8, 2017Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system
Terminated
JAKK142955
Nov 8, 2017Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Terminated
JAKK142955
Nov 8, 2017Siemens Medical Solutions USA, Inc
SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system
Terminated
JAKK142955
Nov 8, 2017Philips Medical Systems (Cleveland) Inc
Philips Healthcare IQon Spectral CT computed tomography x-ray system
Terminated
JAKK133674
Nov 8, 2017Philips Medical Systems (Cleveland) Inc
Philips Healthcare Brilliance iCT SP computed tomography x-ray system
Terminated
JAKK060937
Nov 8, 2017Philips Medical Systems (Cleveland) Inc
Philips Healthcare Brilliance iCT computed tomography x-ray system
Terminated
JAKK060937
Oct 6, 2017Philips Medical Systems (Cleveland) Inc
Philips Ingenuity CT computed tomography x-ray system
Terminated
JAKK160743
Oct 6, 2017Philips Medical Systems (Cleveland) Inc
Philips Ingenuity Core 128 computed tomography x-ray system
Terminated
JAKK160743
Oct 6, 2017Philips Medical Systems (Cleveland) Inc
Philips Ingenuity Core computed tomography x-ray system
Terminated
JAKK160743
Oct 6, 2017Philips Medical Systems (Cleveland) Inc
Philips Brilliance 64 computed tomography x-ray system
Terminated
JAKK160743
Oct 2, 2017Siemens Medical Solutions USA, Inc
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-r
Terminated
JAKK163296
Oct 2, 2017Siemens Medical Solutions USA, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ra
Terminated
JAKK163296
Sep 26, 2017Mobius Imaging, LLC
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding
Terminated
JAKK160126
Jul 28, 2017Brainlab AG
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding
Terminated
JAKK160126
Jul 11, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Terminated
JAKK060937
Jul 11, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Terminated
JAKK060937
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-r
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray t
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tra
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstr
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray t
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray tr
Terminated
JAKK171850
Jun 7, 2017Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstru
Terminated
JAKK171850
May 19, 2017Neusoft Medical Systems Co., Ltd.
Neusoft 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
Terminated
JAKK151383
May 19, 2017Neusoft Medical Systems Co., Ltd.
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software vers
Terminated
JAKNone listed
May 19, 2017GE Healthcare, LLC
GE Healthcare Lightspeed RT16 X-ray system
Terminated
JAKK060052
K082104
May 19, 2017GE Healthcare, LLC
GE Healthcare BrightSpeed X-ray system
Terminated
JAKK052855
K082816
May 19, 2017GE Healthcare, LLC
GE Healthcare lnnova IGS 540 ACT X-ray system
Terminated
JAKK091673
May 19, 2017GE Healthcare, LLC
GE Healthcare Optima CT540 X-ray system
Terminated
JAKK082816
May 19, 2017GE Healthcare, LLC
GE Healthcare Optima CT520 X-ray system
Terminated
JAKK123596
May 19, 2017GE Healthcare, LLC
GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
Terminated
JAKK093581
K132410
May 19, 2017GE Healthcare, LLC
GE Healthcare LightSpeed VCT X-ray system
Terminated
JAKK040372
K061817 +1
May 19, 2017GE Healthcare, LLC
GE Healthcare Optima CT660, CT680 X-ray system
Terminated
JAKK110227
K131576
May 19, 2017GE Healthcare, LLC
GE Healthcare Revolution EVO X-ray system
Terminated
JAKK131576
Feb 23, 2017Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differe
Terminated
JAKK033357
Feb 23, 2017Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differen
Terminated
JAKK033357
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of
Terminated
JAKNone listed
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-
Terminated
JAKNone listed
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction
Terminated
JAKNone listed

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