Device product
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Z-1636-2015
Product summary
- Event
- Event 71127
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units
- Official record key
device-enforcement:Z-1636-2015
Official wording
Reason: The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Code information: UDI *+M709MF100US0/$$+7DN0123MAS*
Distribution pattern: AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
Derived failure modes
-
Unknown
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).