- Device
- SubtleHD-PET (1.x)
- Company
- Subtle Medical, Inc.
- Submission number
- K254013
- Pathway
- 510(k)
- Decision date
- May 14, 2026
- Specialty (lead panel)
- Radiology
- Primary product code
- LLZ
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.