FDA-Device2020-05-20Class II
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Cuattro LLC
Hazard
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Sold states
US: NJ, MI, SC, NC, MI, AR, OUS: None
Affected count
9 units
Manufactured in
150 Capital Dr Ste 280, N/A, Golden, CO, United States
Products
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1934-2020Don't want to check this manually?
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