Miami, FL, US · 1 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QZS | Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer | Class II | General, Plastic Surgery | 1 | 2024-01-12 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-10-13 | Class II | Ongoing | Z-0583-2026 | DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for us… | — | Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-01-12 | DEN230008 | DermaSensor | QZS | Class II | General, Plastic Surgery |