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Aperio GT 450 DX (US) Scanner
LEICA BIOSYSTEMS IMAGING, INC · Model 23GT450DXUS · UDI-DI 00815477020525
1
510(k) clearances
8
Adverse events
2
Recalls
13
Facilities
Description
Aperio GT 450 DX Digital Pathology Scanner is a continuous slide loading while scanning, automated image quality check and Leica universal rack compatibility. Includes 15 Leica universal racks. The Aperio GT 450 DX scanner is an automated digital slide creation instrument. The Aperio GT450 DX scanner is intended for in vitro diagnostic use as an aid to the pathologist to create digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-20 | Ventana Medical Systems, Inc. | Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window |
| 2023-06-06 | Hamamatsu Corporation | 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. |
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Get your free API keyRead the docsData 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.