510(k) · Cleared
ClearedSmartChest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milvue · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on May 10, 2024 as substantially equivalent to K211733 (Lunit, Inc., 2021) after a 274-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- May 10, 2024
- Review
- 274 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 deviceK232410 SmartChestMilvue · 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) | K232410 | SmartChest | Milvue | 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…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code K211733 Lunit INSIGHT CXR Triage QFM IDevice Description Summary… | 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?
SmartChest is a radiological computer assisted triage and notification software that analyzes frontal chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of transitional adolescents (18 - 21 yo but treated like adults) and adults (222 yo) for the presence of suspected pleural effusion and/or pneumothorax. SmartChest uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides…
Read the full statement (133 words)
SmartChest is a radiological computer assisted triage and notification software that analyzes frontal chest X-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of transitional adolescents (18 - 21 yo but treated like adults) and adults (222 yo) for the presence of suspected pleural effusion and/or pneumothorax. SmartChest uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides case-level output available to a PACS (or other DICOM storage platforms) for worklist prioritization.
As a passive notification for prioritization-only software tool within the standard of care workflow, SmartChest does not send a proactive alert directly to a trained medical specialist.
SmartChest is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232410: SmartChest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232410
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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