510(k) · Cleared
ClearedHealthMammo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zebra Medical Vision, Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Jul 16, 2020 as substantially equivalent to K183285 (Curemetrix, Inc., 2019) after a 101-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Jul 16, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 1 generation backK183285 cmTriageCuremetrix, Inc. · 2019
- This deviceK200905 HealthMammoZebra Medical Vision, Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK220080 CogNet QmTRIAGEMedcognetics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252482 CogNet AI-MT+Medcognetics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233108 VinDr-MammoVinbigdata Joint Stock Company · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −1 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| 0 (this device) | K200905 | HealthMammo | Zebra Medical Vision, Ltd. | 2020 | — |
| +1 | K220080 | CogNet QmTRIAGE | Medcognetics, Inc. | 2022 | — |
| +2 | K252482 | CogNet AI-MT+ | Medcognetics, Inc. | 2025 | — |
| +2 | K233108 | VinDr-Mammo | Vinbigdata Joint Stock Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K183285 | cmTriageSummary page 4…Predicate Device: The HealthMammo device is substantially equivalent to the following device: Proprietary Name CmTriage Premarket Notification K183285 Classification Name Radiological Computer-Assisted Prioritization Software Regulation Number 21 CFR 8… | 2019 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220080 | CogNet QmTRIAGE | 2022 | 2 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220080 (Medcognetics, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K183285.
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. 2020, 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?
The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. HealthMammo utilizes 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. HealthMammo produces…
Read the full statement (165 words)
The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with suspicious findings in the medical care environment. HealthMammo utilizes 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. HealthMammo produces an exam-level output to a PACS/Workstation for flagging the suspicious case and allows worklist prioritization.
MQSA-qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography according to the current standard of care. HealthMammo device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician’s worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis.
The HealthMammo device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems 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/K200905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200905: HealthMammo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200905
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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