# K261380: Concentriq AP-Dx

- Pathway: 510(k) (Traditional)
- Applicant: Proscia, Inc.
- Decided: Aug 5, 2026 after 100 days
- Product code: QKQ (Digital Pathology Image Viewing And Management Software)
- Device class: 2
- Regulation: 21 CFR 864.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN160056 (2017). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232202: Aperio GT 450 DX, Leica Biosystems Imaging, Inc. (2024) Summary page 5.
- K230839: Concentriq Dx, Proscia, Inc. (2024) Summary page 5.

## Indications for use
Concentriq AP-Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of pathology primary diagnosis. Concentriq AP-Dx is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using Concentriq AP-Dx.

Source page: https://510kreport.com/device/K261380
Methodology: https://510kreport.com/methodology