510(k) · Cleared
ClearedConcentriq AP-Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proscia, Inc. · QKQ Digital Pathology Image Viewing And Management Software
Cleared on Aug 5, 2026 as substantially equivalent to K232202 (Leica Biosystems Imaging, Inc., 2024) and 1 other predicate after a 100-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Aug 5, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- QKQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN160056 (2017). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK213883 NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K. · 2022 · Recalled
- 1 generation backK230839 Concentriq DxProscia, Inc. · 2024
- This deviceK261380 Concentriq AP-DxProscia, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −2 | K213883 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2022 | 1 |
| −1 | K230839 | Concentriq Dx | Proscia, Inc. | 2024 | — |
| 0 (this device) | K261380 | Concentriq AP-Dx | Proscia, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QKQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QKQ device
- #1 K243449 Infinitt DPSscore 11.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232202 | Aperio GT 450 DXSummary page 5…duct Code(s) QKQ Submission Number K261380 Predicate Device(s) 510(k) Number Predicate Trade Name Product Code K232202 Aperio GT 450 DX PSY K230839 Concentriq Dx… | 2024 |
| * | K230839 | Concentriq DxSummary page 5…s) 510(k) Number Predicate Trade Name Product Code K232202 Aperio GT 450 DX PSY K230839 Concentriq Dx QKQ Purpose for Submission • Addition of Leica Aperio GT… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 8 other devices also cite its predicate K232202.
How does its category compare?
All QKQ devicesQKQ Digital Pathology Image Viewing And Management Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QKQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKQ
226in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKQ
No recall names QKQ since 2007.
Adverse event reports per year · QKQ
No MAUDE report names QKQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 7 | 226 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261380: Concentriq AP-Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261380
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026