# K230839: Concentriq Dx

- Pathway: 510(k) (Traditional)
- Applicant: Proscia, Inc.
- Decided: Feb 8, 2024 after 318 days
- Product code: PSY (Whole Slide Imaging System)
- 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: 2 generations back to DEN160056 (2017). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213883: NanoZoomer S360MD Slide scanner system, Hamamatsu Photonics K.K. (2022) Summary page 5.

## Most influential descendants
- K261380: Concentriq AP-Dx (2026), 0 descendants of its own

## Indications for use
For In Vitro Diagnostic Use Concentriq® 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 primary diagnosis. Concentriq® 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 Dx. Concentriq Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and JVC JD-C240BN01A monitor.

Source page: https://510kreport.com/device/K230839
Methodology: https://510kreport.com/methodology