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Concentriq AP-Dx
Proscia Inc. · Model DX040US · UDI-DI 00860006054595
1
510(k) clearances
8
Adverse events
2
Recalls
13
Facilities
Description
Concentriq AP-Dx is a diagnostic software device for viewing and managing digital pathology slides from FFPE tissue. It aids pathologists in reviewing and interpreting digital slide images for primary diagnosis, specifically with Hamamatsu NanoZoomer S360MD scanner and JVC monitor. The software requires qualified pathologists to ensure image quality and interpretation validity. Not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.
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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