510(k) · Cleared
ClearedMetaLite DX Digital Pathology Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jellox Biotech, Inc. · QKQ Digital Pathology Image Viewing And Management Software
Cleared on Oct 28, 2024 as substantially equivalent to K203845 (Philips Medical Systems Nederland B.V., 2021) after a 269-day review. Its family tree reaches back 4 generations to 2017.
- Decided
- Oct 28, 2024
- Review
- 269 days
- Class
- Class II
- Product code
- QKQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN160056 (2017). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160056 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 3 generations backK172174 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2017
- 2 generations backK192259 Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V. · 2019
- 1 generation backK203845 Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V. · 2021
- This deviceK240303 MetaLite DX Digital Pathology SoftwareJellox Biotech, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN160056 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −3 | K172174 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2017 | — |
| −2 | K192259 | Philips IntelliSite Pathology Solution | Philips Electronics Nederland B.V. | 2019 | — |
| −1 | K203845 | Philips IntelliSite Pathology Solution | Philips Medical Systems Nederland B.V. | 2021 | — |
| 0 (this device) | K240303 | MetaLite DX Digital Pathology Software | Jellox Biotech, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K203845 | Philips IntelliSite Pathology SolutionSummary page 4…Solution (PIPS) Model Number: N/A 510(k) Number: K203845 Manufacturer: Philips Medical Systems Ned… | 2021 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K203845.
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. 2024, 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 MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides. MetaLite DX Digital Pathology Software is not intended for use…
Read the full statement (131 words)
For In Vitro Diagnostic Use
MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides.
MetaLite DX Digital Pathology Software is not intended for use with frozen section, 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. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 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/K240303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240303: MetaLite DX Digital Pathology Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240303
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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