FDA-Device2015-05-27Class II
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
MELA Sciences, Inc.
Hazard
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Sold states
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
Affected count
65 units
Manufactured in
50 S Buckhout St Ste 1, N/A, Irvington, NY, United States
Products
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2015Don't want to check this manually?
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