510(k) · Cleared
ClearedLunit INSIGHT CXR Triage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunit, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Nov 10, 2021 as substantially equivalent to K192320 (Zebra Medical Vision, Ltd., 2019) and 1 other predicate after a 159-day review. Its family tree reaches back 4 generations to 2018. 7 later devices descend from it.
- Decided
- Nov 10, 2021
- Review
- 159 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN170073 (2018). 5 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 1 generation backK183182 Critical Care SuiteGe Medical Systems, LLC · 2019
- This deviceK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK230899 qXR-PTX-PEQure.Ai Technologies · 2023
- Descendant · cites it directly · 0 of its ownK253751 CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026
- Descendant · cites it directly · 0 of its ownK243808 Rayvolve PTX-PEAZmed · 2025
- Descendant · 2 generations on · 0 of its ownK241439 VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK232410 SmartChestMilvue · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K230899qXR-PTX-PEQure.Ai Technologies · 2023 · cites it directly1descendant
- K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026 · cites it directly0descendants
- K243808Rayvolve PTX-PEAZmed · 2025 · cites it directly0descendants
- K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024 · 2 generations on0descendants
- K232410SmartChestMilvue · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −2 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −1 | K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019 | — |
| 0 (this device) | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| +1 | K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023 | — |
| +1 | K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
| +1 | K243808 | Rayvolve PTX-PE | AZmed | 2025 | — |
| +2 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024 | — |
| +1 | K232410 | SmartChest | Milvue | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 K253751 CXRDetectAIscore 12.8 · 5 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 |
|---|---|---|---|
| * | K192320 | HealthCXRSummary page 4…: Primary Predicate Device Manufacturer Name Zebra Medical Vision, Ltd. Device Trade Name HealthCXR 510(k) Number K192320 Secondary Predicate Device Manufacturer Name GE Medical Systems, LLC Device Trade Name Critica… | 2019 |
| * | K183182 | Critical Care SuiteSummary page 4…ary Predicate Device Manufacturer Name GE Medical Systems, LLC Device Trade Name Critical Care Suite 510(k) Number K183182 Lunit, Inc. 15 Floor, 27 Teheran-ro 2-gil, Traditional 510(k)… | 2019 |
| † | K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | 2016 |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K230899 (Qure.Ai Technologies, 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K192320.
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. 2021, 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?
Lunit INSIGHT CXR 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). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization…
Read the full statement (122 words)
Lunit INSIGHT CXR 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). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage.
As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage 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.
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/K211733 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211733: Lunit INSIGHT CXR Triage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211733
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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