510(k) · Cleared
ClearedcmTriage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curemetrix, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Mar 8, 2019 as substantially equivalent to DEN170073 (Viz.Al, Inc., 2018) after a 102-day review. Its family tree reaches back 1 generation to 2018. 37 later devices descend from it.
- Decided
- Mar 8, 2019
- Review
- 102 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170073 (2018). 37 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN170073 ContaCTViz.Al, Inc. · 2018
- This deviceK183285 cmTriageCuremetrix, Inc. · 2019
- Descendant · cites it directly · 23 of its ownK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- Descendant · 2 generations on · 9 of its ownK192320 HealthCXRZebra Medical Vision, Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK183182 Critical Care SuiteGe Medical Systems, LLC · 2019
- Descendant · 3 generations on · 7 of its ownK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K190362HealthPNXZebra Medical Vision, Ltd. · 2019 · cites it directly23descendants
- K192320HealthCXRZebra Medical Vision, Ltd. · 2019 · 2 generations on9descendants
- K183182Critical Care SuiteGe Medical Systems, LLC · 2019 · 2 generations on8descendants
- K211733Lunit INSIGHT CXR TriageLunit, Inc. · 2021 · 3 generations on7descendants
- K192901HealthVCFZebra Medical Vision, Ltd. · 2020 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| 0 (this device) | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| +1 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| +2 | K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019 | — |
| +2 | K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019 | — |
| +3 | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| +1 | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | DEN170073 | ContaCTSummary page 4…Company: Viz.AI Code: QAS 510(k): DEN170073 510(k) Submission Number: K183285 Device Description CureMetrix’s cmTriage is a radiolo… | 2018 |
What descends from it? (37)
See all 374 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?
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. 2019, 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?
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam level. These flags are viewed by the…
Read the full statement (172 words)
cmTriage is a passive notification for prioritization-only, parallel-workflow software tool used by radiologists to prioritize
specific patients within the standard-of-care image worklist for 2D FFDM screening mammograms. cmTriage uses an
artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the
presence of at least one suspicious finding at the exam level. These flags are viewed by the radiologist via their Picture
Archiving and Communication System (PACS) worklist. The decision to use cmTriage codes and how to use cmTriage
codes is ultimately up to the radiologist. cmTriage does not send a proactive alert directly to the radiologist.
Radiologists are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care.
cmTriage is limited to the categorization of exams, does not provide any diagnostic information beyond triage and
prioritization, does not remove images from the radiologist’s worklist, and should not be used in lieu of full patient
evaluation, or relied upon to make or confirm diagnosis.
cmTriage is for prescription use only.
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/K183285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183285: cmTriage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183285
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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