510(k) DEN250028
- Device
- DeepView AI® System
- Applicant
- Spectralmd, Inc.
- 510(k) number
- DEN250028
- Product code
- SHY
- Decision
- Unknown (DENG)
- Decision date
- 2026-05-21
- Date received
- 2025-06-27
- Review panel
- Unknown
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Trudy Estridge
- Address
- 2515 Mckinney Ave. Suite 1000 Dallas TX US 75201 75201
Source Documents#
510(k) summary PDF not indicated by FDA