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) |
|---|---|---|---|
| Jan 11, 2018 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System Terminated |
JAK | K133674 |
| Jan 3, 2018 | Philips 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 |
JAK | K033357 |
| Jan 3, 2018 | Philips 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 |
JAK | K033357 |
| Dec 11, 2017 | Philips 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 |
JAK | K172406 |
| Nov 10, 2017 | Philips 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 |
JAK | K160743 |
| Nov 10, 2017 | Philips 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 |
JAK | K160743 |
| Nov 10, 2017 | Philips 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 |
JAK | K033326 |
| Nov 10, 2017 | Philips 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 |
JAK | K162838 |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Force (Model 10742326) Computed tomography x-ray diagnostic system Terminated |
JAK | K142955 |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash (Model 10430603) Computed tomography x-ray diagnostic system Terminated |
JAK | K142955 |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system Terminated |
JAK | K142955 |
| Nov 8, 2017 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system Terminated |
JAK | K142955 |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare IQon Spectral CT computed tomography x-ray system Terminated |
JAK | K133674 |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare Brilliance iCT SP computed tomography x-ray system Terminated |
JAK | K060937 |
| Nov 8, 2017 | Philips Medical Systems (Cleveland) Inc Philips Healthcare Brilliance iCT computed tomography x-ray system Terminated |
JAK | K060937 |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity CT computed tomography x-ray system Terminated |
JAK | K160743 |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core 128 computed tomography x-ray system Terminated |
JAK | K160743 |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Ingenuity Core computed tomography x-ray system Terminated |
JAK | K160743 |
| Oct 6, 2017 | Philips Medical Systems (Cleveland) Inc Philips Brilliance 64 computed tomography x-ray system Terminated |
JAK | K160743 |
| Oct 2, 2017 | Siemens 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 |
JAK | K163296 |
| Oct 2, 2017 | Siemens 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 |
JAK | K163296 |
| Sep 26, 2017 | Mobius 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 |
JAK | K160126 |
| Jul 28, 2017 | Brainlab 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 |
JAK | K160126 |
| Jul 11, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT - Model 728306 Computed Tomography X-ray systems Terminated |
JAK | K060937 |
| Jul 11, 2017 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP - Model 728311
Brilliance iCT - Model 728306 Computed Tomography X-ray systems Terminated |
JAK | K060937 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| Jun 7, 2017 | Philips 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 |
JAK | K171850 |
| May 19, 2017 | Neusoft 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 |
JAK | K151383 |
| May 19, 2017 | Neusoft 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 |
JAK | None listed |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Lightspeed RT16 X-ray system Terminated |
JAK | K060052 K082104 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare BrightSpeed X-ray system Terminated |
JAK | K052855 K082816 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare lnnova IGS 540 ACT X-ray system Terminated |
JAK | K091673 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT540 X-ray system Terminated |
JAK | K082816 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT520 X-ray system Terminated |
JAK | K123596 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system Terminated |
JAK | K093581 K132410 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare LightSpeed VCT X-ray system Terminated |
JAK | K040372 K061817 +1 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Optima CT660, CT680 X-ray system Terminated |
JAK | K110227 K131576 |
| May 19, 2017 | GE Healthcare, LLC GE Healthcare Revolution EVO X-ray system Terminated |
JAK | K131576 |
| Feb 23, 2017 | Philips 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 |
JAK | K033357 |
| Feb 23, 2017 | Philips 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 |
JAK | K033357 |
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
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