FDA-Device2023-08-09Class II
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Hamamatsu Corporation
Hazard
If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.
Sold states
NY
Affected count
1 unit
Manufactured in
360 Foothill Rd, N/A, Bridgewater, NJ, United States
Products
NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2280-2023Don't want to check this manually?
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