Device product
DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer
Z-0583-2026
Product summary
- Firm
- DERMASENSOR INC
- Event
- Event 97780
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 343 (9 units affected)
- Official record key
device-enforcement:Z-0583-2026
Official wording
Reason: Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Code information: Lot Code: Model No 10101; UDI-DI 085001778610101A9; Serial Number 1010120241230196E4E, 1010120241240151FD5, 101012024130014EF69, 101012024125014F595, 10101202413001F7C66, 1010120242400172717, 101012024325014CE26, 10101202433101D295C, 101012025093012EE03.
Distribution pattern: US distribution to MD, FL, AZ, MS, PA, NY, CT, CA.
Derived failure modes
-
Unknown
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.