FDA-Device2022-01-26Class II
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Konica Minolta Healthcare Americas, Inc.
Hazard
lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed
Sold states
US Nationwide distribution.
Affected count
30 units
Manufactured in
411 Newark Pompton Tpke, N/A, Wayne, NJ, United States
Products
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2022Don't want to check this manually?
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