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Aperio AT2 DX Scanner

LEICA BIOSYSTEMS IMAGING, INC · Model 23AT2DX · UDI-DI 00815477020259

PSY Prescription
1
510(k) clearances
8
Adverse events
2
Recalls
13
Facilities

Description

Aperio AT2 DX Scanner for Primary Diagnosis. Includes installation and one day of training. One year warranty. Must be used in conjunction with Aperio DX Viewing Station for Primary Diagnosis.

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.