DeepView AI® System
FDA 510(k) clearance DEN250028 · decided 2026-05-21
Clearance details
- K-number
- DEN250028
- Device name
- DeepView AI® System
- Applicant
- Spectralmd, Inc.
- Decision
- Unknown
- Date received
- 2025-06-27
- Decision date
- 2026-05-21
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- SHY
- Device class
- 2
- Regulation number
- 878.1840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dallas, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.