510(k) · Cleared
ClearedNovo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PathAI, Inc. · QKQ Digital Pathology Image Viewing And Management Software
Cleared on Aug 11, 2022 as substantially equivalent to DEN160056 (Philips Medical Systems Nederland B.V., 2017) after a 377-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Aug 11, 2022
- Review
- 377 days
- Class
- Class II
- Product code
- QKQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- This deviceK212361 NovoPathAI, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K212361 | Novo | PathAI, Inc. | 2022 | — |
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 K261380 Concentriq AP-Dxscore 12.4 · 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? (1)
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 |
|---|---|---|---|
| * | DEN160056 | Philips IntelliSite Pathology SolutionSummary page 5…88 - Pathology PREDICATE DEVICE Proprietary Name: Philips IntelliSite Pathology Solution (PIPS) Submission Number: DEN160056 DEVICE DESCRIPTION The PathAI Novo device is a web-based software-only device that is intended to aid pathology professionals… | 2017 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate DEN160056.
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. 2022, 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?
Novo 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 digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non- FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to…
Read the full statement (115 words)
Novo 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 digital images of these slides for primary diagnosis. Novo 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, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212361 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212361: Novo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212361
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026