Radiology · 478 clearances · 314 unique sponsors
| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| Ewoosoft Co., Ltd. | 15 | 0 | 2024-07-23 |
| Siemens Medical Solutions USA, Inc. | 10 | 0 | 2024-10-11 |
| Siemens Healthcare GmbH | 8 | 0 | 2025-09-09 |
| GE Medical Systems SCS | 7 | 0 | 2025-04-21 |
| Philips Medical Systems Nederland B.V. | 6 | 0 | 2025-10-02 |
| Shanghai United Imaging Healthcare Co., Ltd. | 6 | 0 | 2025-09-24 |
| Mim Software, Inc. | 6 | 1 | 2025-12-11 |
| GE Healthcare | 5 | 1 | 2026-01-08 |
| Quantib B.V. | 5 | 0 | 2023-04-17 |
| Medacta International S.A. | 5 | 0 | 2025-04-23 |
| Subtle Medical, Inc. | 5 | 1 | 2026-05-14 |
| Brainlab AG | 5 | 1 | 2025-10-16 |
| Canon Medical Systems Corporation | 4 | 0 | 2024-07-17 |
| Konica Minolta, Inc. | 4 | 0 | 2024-05-31 |
| Nobel Biocare AB | 4 | 0 | 2023-12-08 |
| Olea Medical | 4 | 0 | 2023-06-09 |
| Materialise NV | 4 | 1 | 2026-03-12 |
| Brainomix Limited | 4 | 0 | 2025-01-06 |
| Visus Health IT GmbH | 3 | 0 | 2023-07-14 |
| Heuron Co., Ltd. | 3 | 0 | 2023-10-13 |
| JLK, Inc. | 3 | 0 | 2025-02-25 |
| Avatar Medical | 3 | 1 | 2026-03-30 |
| S.M.A.I.O | 3 | 1 | 2026-08-17 |
| Adas3D Medical S.L. | 3 | 0 | 2023-05-23 |
| Claritas Healthtech Pte, Ltd. | 3 | 0 | 2025-08-05 |
Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
|---|---|---|---|---|
| 70553 | CPT | — | Medium | MRI with computer-aided detection; radiological image processing |
| 76376 | CPT | — | Medium | 3D rendering; image reconstruction system component |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-09-23 | K261874 | Syneris | Syneris PACS v.1.0.1.0 |
| 2026-09-22 | K262442 | Replasia BV | HipStudio Analysis |
| 2026-09-18 | K261855 | Elucid Bioimaging, Inc. | Elucid PlaqueIQ |
| 2026-09-15 | K261861 | Mdsim S.A. | SPINEsim v1.0 |
| 2026-09-15 | K254214 | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | OOOPDS |
| 2026-09-04 | K262060 | Radiopharmaceutical Imaging & Dosimetry, LLC | 3D-RD-S |
| 2026-08-17 | K261500 | S.M.A.I.O | KBA3D (v2.4.0) |
| 2026-08-14 | K262449 | ADVAHEALTH SOLUTIONS, LLC | AdvaView |
| 2026-08-12 | K261916 | Cortechs Labs, Inc. | NeuroQuant PET |
| 2026-07-31 | K260936 | Neurocareai, Inc. (Dba Savelife.Ai) | RadioViewAI |
| 2026-07-29 | K260588 | Cleerly, Inc. | Cleerly LABS |
| 2026-07-24 | K262462 | Boston Scientific Corporation | TheraSphere 360 Y-90 Management Platform |
| 2026-07-23 | K262143 | Candelis, Inc. | ImageGrid StreamVue |
| 2026-07-21 | K260500 | ResolutionMD, Inc. | ResolutionMD |
| 2026-07-10 | K262120 | Avara Software | Avara Viewer |
| 2026-07-09 | K253899 | Provect.AI | 3D-Anywhere |
| 2026-07-06 | K261465 | INDIGO TECHNOLOGIES | INDIRA CLOUD VIEWER |
| 2026-06-30 | K260576 | MeVis Medical Solutions AG | MeVis AVM Contour |
| 2026-06-25 | K260231 | Apryse Software Corp | MiPACS V5 (1.0.0) |
| 2026-06-22 | K253421 | Quantified Imaging Limited | Perfusion Measurement Platform v1 |
| 2026-06-08 | K261352 | One Ortho | 2D Hip Planning Software |
| 2026-06-03 | K260116 | CustoMED , Ltd. | CustoMED Viewer |
| 2026-05-27 | K254265 | Videomed Srl ( a Baxter Healthcare Corp company) | Helion Viewer Suite |
| 2026-05-18 | K253831 | Cercare Medical A/S | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT |
| 2026-05-14 | K254013 | Subtle Medical, Inc. | SubtleHD-PET (1.x) |