510(k) · Cleared
ClearedDynamyx Digital Pathology Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inspirata, Inc. · QKQ Digital Pathology Image Viewing And Management Software
Cleared on Mar 1, 2022 as substantially equivalent to K190332 (Leica Biosystems Imaging, Inc., 2019) and 1 other predicate after a 349-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Mar 1, 2022
- Review
- 349 days
- Class
- Class II
- Product code
- QKQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN160056 (2017). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K190332 | Aperio AT2 DX SystemSummary page 4…etary/Trade Leica Aperio AT2 DX Philips IntelliSite Pathology Name System Solution (PIPS) 510(k) Number K190332 DEN160056 Clearance Date May 20, 2019 April 12, 2017 Classification Name Whole Sl… | 2019 |
| * | DEN160056 | Philips IntelliSite Pathology SolutionSummary page 4…Aperio AT2 DX Philips IntelliSite Pathology Name System Solution (PIPS) 510(k) Number K190332 DEN160056 Clearance Date May 20, 2019 April 12, 2017 Classification Name Whole Slide Imaging System Regulat… | 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K190332.
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?
Dynamyx Digital Pathology Software is 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 and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the…
Read the full statement (152 words)
Dynamyx Digital Pathology Software is 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 and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210811 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210811: Dynamyx Digital Pathology Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210811
Report an extraction error
Are you the manufacturer?
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