FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DeepView AI® System
K Number: DEN250028
·
Decision May 21, 2026
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
3
Review Days
328
Basic Information
- Device Name
- DeepView AI® System
- K Number
- DEN250028
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 878.1840
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Spectralmd, Inc.
- Date Received
- June 27, 2025
- Decision Date
- May 21, 2026
- Product Code
- SHY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SHY | Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment. | FDA class 2 | General, Plastic Surgery |