| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-05-15 | K254120 | SubtleHD-CT (1.x) | Subtle Medical, Inc. | Radiology |
| 2026-05-14 | K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | Radiology |
| 2025-02-12 | K243250 | SubtleHD (1.x) | Subtle Medical, Inc. | Radiology |
| 2024-08-21 | K240290 | AiMIFY (1.x) | Subtle Medical, Inc. | Radiology |
| 2024-07-11 | K241329 | SubtleSYNTH (1.x) | Subtle Medical, Inc. | Radiology |
| 2023-05-11 | K223623 | SubtleMR (2.3.x) | Subtle Medical Inc. | Radiology |
| 2021-09-28 | K211964 | SubtlePET | Subtle Medical, Inc. | Radiology |
| 2021-02-26 | K203182 | SubtleMR | Subtle Medical, Inc. | Radiology |
| 2019-09-16 | K191688 | SubtleMR | Subtle Medical, Inc. | Radiology |
| 2018-11-30 | K182336 | SubtlePET | Subtle Medical, Inc. | Radiology |