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 |
|---|---|---|---|
| Jan 12, 2021 | K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i Canon Medical Systems Corporation, JP | JAK |
| Dec 23, 2020 | K202526 | OmniTom Elite Neurologica Corporation, A Subsidiary of Samsung Electronics | JAK |
| Dec 10, 2020 | K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I Canon Medical Systems Corporation, JP | JAK |
| Dec 10, 2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging Ge Medical Systems, LLC | JAK |
| Nov 25, 2020 | K203216 | The Multimodality Advanced Vessel Analysis Philips Medical Systems Nederland B.V., NL | JAK |
| Nov 20, 2020 | K203169 | Revolution Ascend Ge Healthcare Japan Corporation, JP | JAK |
| Nov 18, 2020 | K203187 | HiRise Curvebeam, LLC | JAK |
| Nov 12, 2020 | K193289 | FastStroke, CT Perfusion 4D GE Medical Systems SCS, FR | JAK |
| Oct 29, 2020 | K201092 | LSN Imaging Biometrics, LLC | JAK |
| Oct 11, 2020 | K202213 | syngo.CT Neuro Perfusion Siemens Medical Solutions USA, Inc. | JAK |
| Sep 30, 2020 | K201188 | Clear Guide SCENERGY Clear Guide Medical | JAK |
| Aug 7, 2020 | K200990 | VIDAvision Vida Diagnostics, Inc. | JAK |
| Jul 31, 2020 | K201898 | Clear Guide SCENERGY Clear Guide Medical | JAK |
| Jul 22, 2020 | K193277 | SOMATOM On.site and On.scene Siemens Medical Solutions USA, Inc. | JAK |
| Jul 17, 2020 | K200498 | SCENARIA View Hitachi Healthcare Americas | JAK |
| Jul 9, 2020 | K201586 | XACT Robotic System Xact Robotics, Ltd., IL | JAK |
| Jul 6, 2020 | K193073 | Deep Recon Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| May 14, 2020 | K201053 | PercuNav Image Fusion and Interventional Navigation Philips Ultrasound, Inc. | JAK |
| May 14, 2020 | K201034 | Syngo.CT CaScoring Siemens Medical Solutions USA, Inc. | JAK |
| May 14, 2020 | K193293 | XV Lung Ventilation Analysis Software 4Dx Limited, AU | JAK |
| Apr 1, 2020 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO Siemens Medical Solutions USA, Inc. | JAK |
| Mar 25, 2020 | K200515 | syngo.CT Cardiac Planning Siemens Medical Soultions USA, Inc. | JAK |
| Mar 20, 2020 | K193281 | Hepatic VCAR GE Medical Systems SCS, FR | JAK |
| Mar 16, 2020 | K193267 | Al-Rad Companion (Musculoskeletal) Siemens Medical Solutions USA, Inc. | JAK |
| Mar 5, 2020 | K192590 | CURA 778 Fmi Medical Systems, Inc. | JAK |
| Mar 4, 2020 | K191550 | Broncholab Fluidda, Inc. | JAK |
| Feb 25, 2020 | K200016 | uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd., CN | JAK |
| Feb 21, 2020 | K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i Canon Medical Systems Corporation, JP | JAK |
| Feb 13, 2020 | K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System Canon Medical Systems Corporation, JP | JAK |
| Jan 24, 2020 | K193454 | IQon Spectral CT Philips Medical Systems Nederland B.V., NL | JAK |
| Jan 16, 2020 | K192956 | Auto Positioning Ge Hangwei Medical Systems Co., Ltd., CN | JAK |
| Dec 17, 2019 | K192763 | syngo.CT CaScoring Siemens Medical Solutions USA, Inc. | JAK |
| Dec 13, 2019 | K193170 | Deep Learning Image Reconstruction Ge Healthcare Japan Corporation, JP | JAK |
| Nov 21, 2019 | K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO Siemens Medical Solutions USA, Inc. | JAK |
| Nov 6, 2019 | K191891 | SOMATOM X.cite Siemens Medical Solutions USA, Inc. | JAK |
| Oct 24, 2019 | K192686 | Revolution Maxima, Revolution Ace Ge Hangwei Medical Systems Co., Ltd., CN | JAK |
| Oct 3, 2019 | K192427 | Ablation Confirmation Neuwave Medical, Inc. | JAK |
| Oct 3, 2019 | K191332 | XACT Robotic System Xact Robotics, Ltd., IL | JAK |
| Sep 20, 2019 | K192402 | syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. | JAK |
| Sep 13, 2019 | K190841 | SCENARIA View Hitachi Healthcare Americas | JAK |
| Sep 10, 2019 | K183268 | AI-Rad Companion (Cardiovascular) Siemens Medical Solutions USA, Inc. | JAK |
| Sep 6, 2019 | K192188 | Aquilion ONE (TSX-306A/3) V10.0 Canon Medical Systems Corporation, JP | JAK |
| Aug 7, 2019 | K191394 | ILLUMISITE Platform Covidien, LLC | JAK |
| Jul 29, 2019 | K191136 | Access CT Philips Healthcare (Suzhou) Co., Ltd., CN | JAK |
| Jul 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC | JAK |
| Jul 26, 2019 | K183271 | AI-Rad Companion (Pulmonary) Siemens Medical Solutions USA, Inc. | JAK |
| Jul 5, 2019 | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE Canon Medical Systems Corporation, JP | JAK |
| Jul 3, 2019 | K191468 | syngo.CT Dual Energy Siemens Medical Solutions USA, Inc. | JAK |
| Jun 27, 2019 | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edg Siemens Medical Solutions USA, Inc. | JAK |
| Jun 12, 2019 | K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE Canon Medical Systems Corporation, JP | JAK |
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