510(k) · Cleared
ClearedRadify Triage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envisionit Deepai, Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Jan 17, 2024 as substantially equivalent to K211733 (Lunit, Inc., 2021) after a 205-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Jan 17, 2024
- Review
- 205 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 3 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 2 generations backK183182 Critical Care SuiteGe Medical Systems, LLC · 2019
- 1 generation backK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- This deviceK231871 Radify TriageEnvisionit Deepai, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −3 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −2 | K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019 | — |
| −1 | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| 0 (this device) | K231871 | Radify Triage | Envisionit Deepai, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 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 |
|---|---|---|---|
| * | K211733 | Lunit INSIGHT CXR TriageSummary page 4…o the following devices: Primary Predicate: Manufacturer Name Lunit Inc Device Trade Name Lunit INSIGHT CXR Triage 510(k) Number K211733 4. INTENDED USE/INDICATIONS FOR USE RADIFY® Triage is a radiological computer-assisted triage and notification software that a… | 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 6 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- 5 other devices also cite its predicate K211733.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM 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 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RADIFY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage. As a passive…
Read the full statement (134 words)
RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax).
RADIFY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within the standard of care workflow, RADIFY® Triage does not send a proactive alert directly to the appropriately trained medical specialists. The product is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The device does not remove the cases from the queue and does not flag the condition as being absent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231871: Radify Triage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231871
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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