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 1 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261225 | CAS-One IR | Cascination AG | 2026-09-29 | Traditional | PDF ↗ |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026-09-22 | Traditional | PDF ↗ |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | 2026-09-18 | Traditional | PDF ↗ |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | 2026-09-04 | Traditional | PDF ↗ |
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 | Traditional | PDF ↗ |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 | Traditional | PDF ↗ |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 | Traditional | PDF ↗ |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 | Traditional | PDF ↗ |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 | Traditional | PDF ↗ |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 | Traditional | PDF ↗ |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 | Traditional | PDF ↗ |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 | Traditional | PDF ↗ |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 | Traditional | PDF ↗ |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 | Traditional | PDF ↗ |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 | Traditional | PDF ↗ |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 | Traditional | PDF ↗ |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 | Traditional | PDF ↗ |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 | Traditional | PDF ↗ |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 | Traditional | PDF ↗ |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 | Traditional | PDF ↗ |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 | Traditional | PDF ↗ |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 | Traditional | PDF ↗ |
| K250766 | LungQ 4 | Thirona BV | 2025-10-02 | Traditional | PDF ↗ |
| K251645 | Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP | Canon Medical Systems Corporation | 2025-09-26 | Traditional | PDF ↗ |
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | 2025-09-08 | Traditional | PDF ↗ |
| K251484 | CT:VQ | 4Dmedical Limited | 2025-08-28 | Traditional | PDF ↗ |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | 2025-08-01 | Traditional | PDF ↗ |
| K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025-07-28 | Traditional | PDF ↗ |
| K250970 | Marie | Leo Cancer Care | 2025-07-25 | Traditional | PDF ↗ |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | 2025-07-03 | Traditional | PDF ↗ |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | 2025-06-27 | Traditional | PDF ↗ |
| K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025-06-20 | Traditional | PDF ↗ |
| K243672 | CardIQ Suite | GE Medical Systems SCS | 2025-06-18 | Traditional | PDF ↗ |
| K250370 | SCENARIA View Phase 5.0 | Fujifilm Corporation | 2025-05-20 | Traditional | PDF ↗ |
| K244008 | Spectral CT | Philips Medical Systems Technologies , Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 | Traditional | PDF ↗ |
| K250650 | SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. | 2025-04-15 | Traditional | PDF ↗ |
| K243240 | Vitrea CT VScore | Canon Medical Informatics, Inc. | 2025-04-10 | Traditional | PDF ↗ |
| K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | 2025-03-14 | Traditional | PDF ↗ |
| K242411 | Brainomix 360 e-Lung | Brainomix Limited | 2025-02-19 | Traditional | PDF ↗ |
| K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K243229 | Bunkerhill AVC | BunkerHill Health | 2025-01-27 | Traditional | PDF ↗ |
| K241166 | uCT 550 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 | Traditional | PDF ↗ |
| K241200 | SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option | Arineta , Ltd. | 2025-01-13 | Traditional | PDF ↗ |
| K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 | Traditional | PDF ↗ |
| K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-01-03 | Traditional | PDF ↗ |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024-12-23 | Traditional | PDF ↗ |
| K242188 | ClearRead CT CAC | Riverain Technologies, Inc. | 2024-12-03 | Traditional | PDF ↗ |
| K242874 | Gating Reflector Block | Varian Medical Systems, Inc. | 2024-11-21 | Traditional | PDF ↗ |
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologies , Ltd. | 2024-10-18 | Traditional | PDF ↗ |
| K240369 | CAC (gated) Algorithm | BunkerHill Health | 2024-09-27 | Traditional | PDF ↗ |
| K241295 | SOMATOM On.site | Siemens Medical Solutions USA, Inc. | 2024-09-03 | Traditional | PDF ↗ |
| K241440 | HealthCCSng | Nano-X AI , Ltd. | 2024-08-19 | Special | PDF ↗ |
| K233731 | CardIQ Suite | GE Medical Systems SCS | 2024-08-01 | Traditional | PDF ↗ |
| K241713 | HiRise (1040-230) | Curvebeam, LLC | 2024-07-12 | Special | PDF ↗ |
| K233767 | OmniTom Elite | Neurologica Corporation | 2024-06-10 | Traditional | PDF ↗ |
| K233875 | Brainomix 360 e-Lung | Brainomix Limited | 2024-05-13 | Traditional | PDF ↗ |
| K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | 2024-05-03 | Traditional | PDF ↗ |
| K233583 | FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation | 2024-04-26 | Traditional | PDF ↗ |
| K233698 | True Enhance DL | Ge Healthcare Japan Corporation | 2024-04-11 | Traditional | PDF ↗ |
| K232227 | ABLATE-IQ | Neuwave Medical, Inc. | 2024-04-04 | Traditional | PDF ↗ |
| K233750 | ECG-less Cardiac | Ge Medical Systems, LLC | 2024-04-02 | Traditional | PDF ↗ |
| K232835 | Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System | Canon Medical Systems Corporation | 2024-04-02 | Traditional | PDF ↗ |
| K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K233650 | SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2024-03-26 | Traditional | PDF ↗ |
| K233753 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | 2024-03-21 | Abbreviated | PDF ↗ |
| K232022 | CAS-One IR | Cascination AG | 2024-03-13 | Traditional | PDF ↗ |
| K233749 | Revolution Ascend Sliding | Ge Hangwei Medical Systems Co., Ltd. | 2024-02-22 | Special | PDF ↗ |
| K233080 | HealthFLD | Nano-X AI , Ltd. | 2024-02-08 | Traditional | PDF ↗ |
| K234030 | Clear Guide SCENERGY | Clear Guide Medical | 2024-01-17 | Special | PDF ↗ |
| K232412 | LungQ v3.0.0 | Thirona BV | 2024-01-08 | Traditional | PDF ↗ |
| K232136 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | 2024-01-04 | Traditional | PDF ↗ |
| K233334 | Aquilion Serve SP (TSX-307B/1) V1.3 | Canon Medical Systems Corporation | 2023-12-06 | Special | PDF ↗ |
| K232206 | SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | 2023-12-06 | Traditional | PDF ↗ |
| K232155 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2023-11-30 | Traditional | PDF ↗ |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 | Traditional | PDF ↗ |
| K231631 | BriefCase-Quantification | Aidoc Medical , Ltd. | 2023-11-28 | Traditional | PDF ↗ |
| K232392 | CT Lung Ventilation Analysis Software (CT:V) | 4Dmedical Limited | 2023-11-16 | Traditional | PDF ↗ |
| K232045 | MeVis Liver Suite | MeVis Medical Solutions AG | 2023-10-27 | Traditional | PDF ↗ |
| K230370 | SpotLight/SpotLight Duo (with DLIR option) | Arineta , Ltd. | 2023-10-13 | Traditional | PDF ↗ |
| K231574 | Scenaria View 4.2 | FUJIFILM Healthcare Americas Corporation | 2023-10-12 | Traditional | PDF ↗ |
| K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2023-10-11 | Traditional | PDF ↗ |
| K230130 | Micromate Navi+ | Isys Medizintechnik GmbH | 2023-10-10 | Traditional | PDF ↗ |
| K231281 | Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation | 2023-09-19 | Traditional | PDF ↗ |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 | Traditional | PDF ↗ |
| K223424 | Spine Auto Views | GE Medical Systems SCS | 2023-07-13 | Traditional | PDF ↗ |
| K223261 | Open Rib | Canon Medical Informatics, Inc. | 2023-07-13 | Traditional | PDF ↗ |
| K230421 | SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc. | 2023-06-16 | Traditional | PDF ↗ |
| K230112 | CAC Software | Imbio, Inc. | 2023-06-13 | Traditional | PDF ↗ |
| K223447 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung | 2023-06-01 | Traditional | PDF ↗ |
| K223758 | Epione | Quantum Surgical Sas | 2023-05-03 | Traditional | PDF ↗ |
| K230223 | iCAC Device | Bunkerhill, Inc. | 2023-04-25 | Traditional | PDF ↗ |
| K230807 | Deep Learning Image Reconstruction | Ge Healthcare Japan Corporation | 2023-04-20 | Special | PDF ↗ |
| K222360 | AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions U.S.A. | 2023-04-06 | Traditional | PDF ↗ |
| K223514 | Spectral Bone Marrow | Ge Medical Systems, LLC | 2023-03-09 | Traditional | PDF ↗ |
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | 2023-03-07 | Traditional | PDF ↗ |
| K222819 | Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i | Canon Medical Systems Corporation | 2023-03-03 | Traditional | PDF ↗ |
| K223028 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2023-02-16 | Traditional | PDF ↗ |
| K223804 | PercuNav Image Fusion and Interventional Navigation System | Philips Ultrasound, LLC | 2023-01-18 | Traditional | PDF ↗ |
Product code JAK · Class II · Radiology. Data: openFDA.