Subtle Medical, Inc.
9 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| May 15, 2026 | K254120 | SubtleHD-CT (1.x) | Radiology | QIH |
| May 14, 2026 | K254013 | SubtleHD-PET (1.x) | Radiology | LLZ |
| February 12, 2025 | K243250 | SubtleHD (1.x) | Radiology | QIH |
| August 21, 2024 | K240290 | AiMIFY (1.x) | Radiology | LLZ |
| July 11, 2024 | K241329 | SubtleSYNTH (1.x) | Radiology | QIH |
| September 28, 2021 | K211964 | SubtlePET | Radiology | KPS |
| February 26, 2021 | K203182 | SubtleMR | Radiology | LLZ |
| September 16, 2019 | K191688 | SubtleMR | Radiology | LLZ |
| November 30, 2018 | K182336 | SubtlePET | Radiology | KPS |