Menlo Park, CA, US · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 5 | 2026-05-14 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 3 | 2026-05-15 |
| KPS | System, Tomography, Computed, Emission | Class II | Radiology | 1 | 2021-09-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-15 | K254120 | SubtleHD-CT (1.x) | QIH | Class II | Radiology |
| 2026-05-14 | K254013 | SubtleHD-PET (1.x) | LLZ | Class II | Radiology |
| 2025-02-12 | K243250 | SubtleHD (1.x) | QIH | Class II | Radiology |
| 2024-08-21 | K240290 | AiMIFY (1.x) | LLZ | Class II | Radiology |
| 2024-07-11 | K241329 | SubtleSYNTH (1.x) | QIH | Class II | Radiology |
| 2024-04-29 | K233699 | SubtleREFORMAT (1.x) | LLZ | Class II | Radiology |
| 2023-05-11 | K223623 | SubtleMR (2.3.x) | LLZ | Class II | Radiology |
| 2021-09-28 | K211964 | SubtlePET | KPS | Class II | Radiology |
| 2021-02-26 | K203182 | SubtleMR | LLZ | Class II | Radiology |