FDA Product Code
FDA Product Code JAK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1750
510(k) Clearances — 826 records · page 2 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223311 | Philips CT 3500 | Philips Healthcare (Suzhou) Co., Ltd. | 2022-12-22 | Traditional | PDF ↗ |
| K213465 | CardioGraphe | Arineta , Ltd. | 2022-12-02 | Traditional | PDF ↗ |
| K222361 | AI-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | 2022-10-20 | Traditional | PDF ↗ |
| K213759 | XACT Robotic System, ACE Model | Xact Robotics, Ltd. | 2022-09-23 | Traditional | PDF ↗ |
| K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | 2022-09-12 | Traditional | PDF ↗ |
| K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2022-08-11 | Traditional | PDF ↗ |
| K220910 | Medical image processing software | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | 2022-08-11 | Traditional | PDF ↗ |
| K220961 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2022-07-29 | Special | PDF ↗ |
| K221727 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022-07-13 | Special | PDF ↗ |
| K220814 | NAEOTOM Alpha, Scan&GO Software | Siemens Medical Solutions USA, Inc. | 2022-07-12 | Traditional | PDF ↗ |
| K213504 | Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A | Canon Medical Systems Corporation | 2022-06-16 | Traditional | PDF ↗ |
| K213829 | SCENARIA View | Fujifilm Healthcare Corporation | 2022-05-23 | Traditional | PDF ↗ |
| K221219 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2022-05-17 | Special | PDF ↗ |
| K221116 | XACT ACE Robotic System | Xact Robotics, Ltd. | 2022-05-13 | Special | PDF ↗ |
| K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | 2022-05-13 | Traditional | PDF ↗ |
| K220664 | NewTom 7G | Cefla S.C. | 2022-05-06 | Traditional | PDF ↗ |
| K211180 | Liver Suite | GE Medical Systems SCS | 2022-05-02 | Traditional | PDF ↗ |
| K213649 | BodyTom 64 | Neurologica Corporation | 2022-04-29 | Traditional | PDF ↗ |
| K212441 | Philips Incisive CT | Philips Healthcare (Suzhou) Co., Ltd. | 2022-04-27 | Traditional | PDF ↗ |
| K213944 | HealthOST | Nanoxai , Ltd. | 2022-04-22 | Traditional | PDF ↗ |
| K212889 | Syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2022-03-28 | Traditional | PDF ↗ |
| K213725 | CardIQ Suite | GE Medical Systems SCS | 2022-03-11 | Traditional | PDF ↗ |
| K220450 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2022-03-07 | Special | PDF ↗ |
| K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2022-02-25 | Traditional | PDF ↗ |
| K211645 | Epione | Quantum Surgical Sas | 2022-02-24 | Traditional | PDF ↗ |
| K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022-02-18 | Traditional | PDF ↗ |
| K213938 | Revolution Ascend | Ge Healthcare Japan Corporation | 2022-02-04 | Traditional | PDF ↗ |
| K214019 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2022-01-20 | Special | PDF ↗ |
| K210760 | Precise Image | Philips Medical Systems Nederland B.V. | 2022-01-14 | Traditional | PDF ↗ |
| K213927 | Respiratory Gating for Scanners v2.0 | Varian Medical Systems, Inc. | 2022-01-14 | Special | PDF ↗ |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition | Ge Medical Systems, LLC | 2021-12-17 | Special | PDF ↗ |
| K213096 | Al-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2021-12-06 | Traditional | PDF ↗ |
| K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | 2021-11-22 | Traditional | PDF ↗ |
| K211591 | NAEOTOM Alpha, Scan&GO | Siemens Medical Solutions USA, Inc. | 2021-09-30 | Traditional | PDF ↗ |
| K212067 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2021-09-17 | Traditional | PDF ↗ |
| K210085 | HealthCCSng | Zebra Medical Vision, Ltd. | 2021-09-15 | Traditional | PDF ↗ |
| K211828 | Aquilion Exceed LB | Canon Medical Systems Corporation | 2021-09-10 | Traditional | PDF ↗ |
| K212494 | Lung Image Analysis | Pulmonx Corporation | 2021-09-02 | Traditional | PDF ↗ |
| K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software | Siemens Medical Solutions USA, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K203448 | uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 | Traditional | PDF ↗ |
| K203411 | syngo.CT Skull Unfolding | Siemens Medical Solutions USA, Inc. | 2021-07-22 | Traditional | PDF ↗ |
| K203720 | MICROMATE | Isys Medizintechnik GmbH | 2021-06-22 | Traditional | PDF ↗ |
| K203514 | Precise Position | Philips Healthcare (Suzhou) Co., Ltd. | 2021-06-17 | Traditional | PDF ↗ |
| K203699 | syngo. CT Extended Functionalities | Siemens Medical Solutions USA, Inc. | 2021-04-30 | Traditional | PDF ↗ |
| K203225 | Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System | Canon Medical Systems Corporation | 2021-03-24 | Traditional | PDF ↗ |
| K203617 | MaxFOV 2 | Ge Medical Systems, LLC | 2021-03-02 | Traditional | PDF ↗ |
| K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021-02-26 | Traditional | PDF ↗ |
| K200626 | VesselIQ Xpress | GE Medical Systems SCS | 2021-02-16 | Traditional | PDF ↗ |
| K201231 | CTxx85 CT Scanner | Analogic Corporation | 2021-02-02 | Traditional | PDF ↗ |
| K201836 | Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2021-01-12 | Traditional | PDF ↗ |
| K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 | Traditional | PDF ↗ |
| K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging | Ge Medical Systems, LLC | 2020-12-10 | Traditional | PDF ↗ |
| K203042 | Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I | Canon Medical Systems Corporation | 2020-12-10 | Traditional | PDF ↗ |
| K203216 | The Multimodality Advanced Vessel Analysis | Philips Medical Systems Nederland B.V. | 2020-11-25 | Traditional | PDF ↗ |
| K203169 | Revolution Ascend | Ge Healthcare Japan Corporation | 2020-11-20 | Special | PDF ↗ |
| K203187 | HiRise | Curvebeam, LLC | 2020-11-18 | Traditional | PDF ↗ |
| K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | 2020-11-12 | Traditional | PDF ↗ |
| K201092 | LSN | Imaging Biometrics, LLC | 2020-10-29 | Traditional | PDF ↗ |
| K202213 | syngo.CT Neuro Perfusion | Siemens Medical Solutions USA, Inc. | 2020-10-11 | Traditional | PDF ↗ |
| K201188 | Clear Guide SCENERGY | Clear Guide Medical | 2020-09-30 | Traditional | PDF ↗ |
| K200990 | VIDAvision | Vida Diagnostics, Inc. | 2020-08-07 | Traditional | PDF ↗ |
| K201898 | Clear Guide SCENERGY | Clear Guide Medical | 2020-07-31 | Traditional | PDF ↗ |
| K193277 | SOMATOM On.site and On.scene | Siemens Medical Solutions USA, Inc. | 2020-07-22 | Traditional | PDF ↗ |
| K200498 | SCENARIA View | Hitachi Healthcare Americas | 2020-07-17 | Traditional | PDF ↗ |
| K201586 | XACT Robotic System | Xact Robotics, Ltd. | 2020-07-09 | Special | PDF ↗ |
| K193073 | Deep Recon | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 | Traditional | PDF ↗ |
| K201053 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2020-05-14 | Traditional | PDF ↗ |
| K201034 | Syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2020-05-14 | Special | PDF ↗ |
| K193293 | XV Lung Ventilation Analysis Software | 4Dx Limited | 2020-05-14 | Traditional | PDF ↗ |
| 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. | 2020-04-01 | Special | PDF ↗ |
| K200515 | syngo.CT Cardiac Planning | Siemens Medical Soultions USA, Inc. | 2020-03-25 | Special | PDF ↗ |
| K193281 | Hepatic VCAR | GE Medical Systems SCS | 2020-03-20 | Traditional | PDF ↗ |
| K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | 2020-03-16 | Traditional | PDF ↗ |
| K192590 | CURA 778 | Fmi Medical Systems, Inc. | 2020-03-05 | Traditional | PDF ↗ |
| K191550 | Broncholab | Fluidda, Inc. | 2020-03-04 | Traditional | PDF ↗ |
| K200016 | uCT 530, uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2020-02-25 | Traditional | PDF ↗ |
| K192832 | Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i | Canon Medical Systems Corporation | 2020-02-21 | Traditional | PDF ↗ |
| K192828 | Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System | Canon Medical Systems Corporation | 2020-02-13 | Traditional | PDF ↗ |
| K193454 | IQon Spectral CT | Philips Medical Systems Nederland B.V. | 2020-01-24 | Traditional | PDF ↗ |
| K192956 | Auto Positioning | Ge Hangwei Medical Systems Co., Ltd. | 2020-01-16 | Traditional | PDF ↗ |
| K192763 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | 2019-12-17 | Traditional | PDF ↗ |
| K193170 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2019-12-13 | Special | PDF ↗ |
| 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. | 2019-11-21 | Traditional | PDF ↗ |
| K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | 2019-11-06 | Traditional | PDF ↗ |
| K192686 | Revolution Maxima, Revolution Ace | Ge Hangwei Medical Systems Co., Ltd. | 2019-10-24 | Special | PDF ↗ |
| K191332 | XACT Robotic System | Xact Robotics, Ltd. | 2019-10-03 | Traditional | PDF ↗ |
| K192427 | Ablation Confirmation | Neuwave Medical, Inc. | 2019-10-03 | Special | PDF ↗ |
| K192402 | syngo.CT Extended Functionality | Siemens Medical Solutions USA, Inc. | 2019-09-20 | Special | PDF ↗ |
| K190841 | SCENARIA View | Hitachi Healthcare Americas | 2019-09-13 | Traditional | PDF ↗ |
| K183268 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | 2019-09-10 | Traditional | PDF ↗ |
| K192188 | Aquilion ONE (TSX-306A/3) V10.0 | Canon Medical Systems Corporation | 2019-09-06 | Special | PDF ↗ |
| K191394 | ILLUMISITE Platform | Covidien, LLC | 2019-08-07 | Traditional | PDF ↗ |
| K191136 | Access CT | Philips Healthcare (Suzhou) Co., Ltd. | 2019-07-29 | Traditional | PDF ↗ |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | Ge Medical Systems, LLC | 2019-07-26 | Special | PDF ↗ |
| K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2019-07-26 | Traditional | PDF ↗ |
| K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | 2019-07-05 | Traditional | PDF ↗ |
| K191468 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2019-07-03 | Special | PDF ↗ |
| K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence | Siemens Medical Solutions USA, Inc. | 2019-06-27 | Traditional | PDF ↗ |
| K183046 | Aquilion ONE (TSX-305A/6) V8.9 with AiCE | Canon Medical Systems Corporation | 2019-06-12 | Traditional | PDF ↗ |
| K190505 | Low Dose Lung Screening Option | Canon Medical Systems Corporation | 2019-06-05 | Traditional | PDF ↗ |
Product code JAK · Class II · Radiology. Data: openFDA.