510(k) · Cleared
ClearedFullFocus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paige.Ai, Inc. · QKQ Digital Pathology Image Viewing And Management Software
Cleared on Jan 9, 2025 as substantially equivalent to K232202 (Leica Biosystems Imaging, Inc., 2024) and 1 other predicate after a 248-day review. Its family tree reaches back 3 generations to 2017.
- Decided
- Jan 9, 2025
- Review
- 248 days
- Class
- Class II
- Product code
- QKQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN160056 (2017). 4 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 backK190332 Aperio AT2 DX SystemLeica Biosystems Imaging, Inc. · 2019
- 1 generation backK232202 Aperio GT 450 DXLeica Biosystems Imaging, Inc. · 2024
- This deviceK241273 FullFocusPaige.Ai, Inc. · 2025
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 | K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | 2019 | — |
| −1 | K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 | — |
| 0 (this device) | K241273 | FullFocus | Paige.Ai, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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 |
|---|---|---|---|
| * | K232202 | Aperio GT 450 DXSummary page 5…88 – Pathology Common Name: FullFocus 510(k) Number: K241273 Predicate Devices Trade name: 1. Aperio GT450X (K232202) Manufacturer: Leica Biosystems Imaging, Inc. 2. NanoZoomer S360MD Slide scanner system (K213883) Manufacturer:… | 2024 |
| * | K213883 | NanoZoomer S360MD Slide scanner systemSummary page 5…K241273 Predicate Devices Trade name: 1. Aperio GT450X (K232202) Manufacturer: Leica Biosystems Imaging, Inc. 2. NanoZoomer S360MD Slide scanner system (K213883) Manufacturer: Hamamatsu Photonics K.K. Device Class: Class II CFR section: 864.3700 Product code: PSY Classification nam… | 2022 |
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 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 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. 2025, 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?
For In Vitro Diagnostic Use FullFocus is a software 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 pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility…
Read the full statement (113 words)
For In Vitro Diagnostic Use
FullFocus is a software 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 pathology slides for primary diagnosis. FullFocus 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. FullFocus is intended to be used with the interoperable components specified in the below Table.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241273: FullFocus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241273
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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