FDA AI Clearance Tracker/DEN250028
General and Plastic Surgery · De Novo
DeepView AI® System
spectralmd, inc.
- Device
- DeepView AI® System
- Company
- spectralmd, inc.
- Submission number
- DEN250028
- Pathway
- De Novo
- Decision date
- May 21, 2026
- Specialty (lead panel)
- General and Plastic Surgery
- Primary product code
- SHY
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.