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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2017 | K170716 | PercuNav Image Fusion and Interventional Navigation Philips Ultrasound, Inc. | JAK |
| Apr 21, 2017 | K170221 | syngo.CT Cardiac Planning Siemens Healthcare GmbH, DE | JAK |
| Apr 7, 2017 | K162838 | Philips iCT CT System Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 5, 2017 | K163711 | IQon Spectral CT Philips Medical Systems (Cleveland), Inc. | JAK |
| Mar 24, 2017 | K163297 | Scan&GO Siemens Medical Solutions USA, Inc. | JAK |
| Mar 21, 2017 | K163296 | SOMATOM go.Up, SOMATOM go.Now Siemens Medical Solutions USA, Inc. | JAK |
| Mar 3, 2017 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. | JAK |
| Mar 1, 2017 | K163284 | syngo. CT Neuro Perfusion Siemens Medical Solutions USA, Inc. | JAK |
| Feb 9, 2017 | K163341 | syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. | JAK |
| Feb 9, 2017 | K163289 | syngo. CT Single Source Dual Energy (twin beam) Siemens Medical Solutions USA, Inc., Ultrasound DI | JAK |
| Feb 2, 2017 | K170019 | Aquilion Lightning, TSX-036A/1, V8.4 Toshibamedical Systems Corporation, JP | JAK |
| Jan 26, 2017 | K163281 | FastStroke Gef Medical Systems Scs, FR | JAK |
| Dec 16, 2016 | K163213 | Revolution CT Ge Medical Systems, LLC | JAK |
| Dec 16, 2016 | K162302 | Somatom Confidence ® RT Pro Siemens Medical Solutions USA, Inc. | JAK |
| Nov 3, 2016 | K161157 | Vitrea CT Dual Energy Image View Vital Images, Inc. | JAK |
| Aug 30, 2016 | K160723 | OnSight 3D Extremity System Carestream Health, Inc. | JAK |
| Aug 24, 2016 | K161196 | SOMATOM Drive Siemens Medical Solutions USA, Inc. | JAK |
| Aug 17, 2016 | K161748 | SUPRIA w/guideShot Option Hitachi Medical Systems America, Inc. | JAK |
| Aug 10, 2016 | K161066 | SpotLight CT Arineta , Ltd., IL | JAK |
| Aug 8, 2016 | K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc. | JAK |
| Aug 8, 2016 | K160611 | P-ARTIS P-Cure, Ltd., IL | JAK |
| Jul 22, 2016 | K161009 | Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4 Toshibamedical Systems Corporation, JP | JAK |
| Jun 29, 2016 | K161285 | Ablation Confirmation Neuwave Medical, Inc. | JAK |
| Jun 29, 2016 | K153360 | ADMIRE Siemens Medi Cal Solutions, Inc. | JAK |
| Jun 16, 2016 | K160350 | ECG CT Gating Device Neocoil, LLC | JAK |
| Jun 9, 2016 | K160587 | Aquilion ONE (TSX-305A/3) V7.3 Toshibamedical Systems Corporation, JP | JAK |
| May 17, 2016 | K153331 | SafeCT-29 Medic Vision Imaging Solutions, IL | JAK |
| Apr 19, 2016 | K160126 | AIRO Computed Tomography (CT) X-ray System Mobius Imaging | JAK |
| Apr 8, 2016 | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 1, 2016 | K153263 | Aquilion Lightning, TSX-035A/4 and /5, V7.0 Toshibamedical Systems Corporation, JP | JAK |
| Mar 25, 2016 | K151765 | SOMATOM Perspective Siemens Medical Solutions USA, Inc. | JAK |
| Mar 18, 2016 | K151749 | somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc. | JAK |
| Mar 9, 2016 | K153429 | SmartView 3D Option Ge Hangwei Medical System Co., Ltd., CN | JAK |
| Feb 19, 2016 | K153220 | syngo.CT Single Source Dual Energy (Twin Beam) Siemens Medical Solutions USA, Inc. | JAK |
| Feb 12, 2016 | K153004 | Clear Guide SCENERGY Clear Guide Medical | JAK |
| Jan 20, 2016 | K152584 | Stroke VCAR GE Medical Systems SCS, FR | JAK |
| Jan 20, 2016 | K152473 | CAS-One IR Cascination AG, CH | JAK |
| Nov 27, 2015 | K151673 | Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) Toshibamedical Systems Corporation, JP | JAK |
| Nov 24, 2015 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, Siemens Medical Solutions USA, Inc. | JAK |
| Nov 20, 2015 | K151414 | IQQA Guide Edda Technology | JAK |
| Nov 12, 2015 | K151752 | SOMATOM Emotion 6/16 Siemens Medical Solutions USA, Inc. | JAK |
| Nov 5, 2015 | K151376 | superDimension Navigation System Covidien, LLC | JAK |
| Nov 4, 2015 | K151383 | NeuViz 128 Multi-slice CT Scanner System Neusoft Medical Systems Co., Ltd., CN | JAK |
| Nov 2, 2015 | K150713 | syngo.CT Myocardial Perfusion Siemens Medical Solutions USA, Inc. | JAK |
| Oct 30, 2015 | K151283 | Lung Analysis Software Vital Images, Inc. | JAK |
| Oct 30, 2015 | K150595 | SCENARIA Phase 3 Whole-body X-ray CT System Hitachi Medical Systems America, Inc. | JAK |
| Oct 10, 2015 | K151919 | Vitrea CT Lung Density Analysis Software Vital Images, Inc. | JAK |
| Oct 9, 2015 | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc. | JAK |
| Oct 9, 2015 | K151833 | Aquilion Lightning (TSX-035A/2, V7.0) Toshibamedical Systems Corporation, JP | JAK |
| Sep 30, 2015 | K150565 | Supria Whole-body X-ray CT System Hitachi Medical Systems America, Inc. | JAK |
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