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NanoZoomer S360MD Slide scanner system

HAMAMATSU PHOTONICS K.K. · Model C13220-01MD · UDI-DI 04582389010659

PSY Prescription
3
510(k) clearances
8
Adverse events
2
Recalls
13
Facilities

Recalls

DateFirmReason
2026-04-20Ventana Medical Systems, Inc.Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
2023-06-06Hamamatsu CorporationIf the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the whole slide image (WSI) of a different patient.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.