510(k) · Cleared
ClearedHealthVCF
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 May 12, 2020 as substantially equivalent to K183285 (Curemetrix, Inc., 2019) after a 210-day review. Its family tree reaches back 2 generations to 2018. 6 later devices descend from it.
- Decided
- May 12, 2020
- Review
- 210 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 1 generation backK183285 cmTriageCuremetrix, Inc. · 2019
- This deviceK192901 HealthVCFZebra Medical Vision, Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK193271 uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK213319 Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK222692 BriefCaseAidoc Medical, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK240612 Cina-VCFAvicenna.Ai · 2024
- Descendant · 3 generations on · 0 of its ownK230074 Rapid Aneurysm Triage and NotificationIschemaview, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193271uAI EasyTriage-RibShanghai United Imaging Intelligence Co., Ltd. · 2021 · cites it directly3descendants
- K213319Viz ANEURYSM, Viz ANXViz. Ai, Inc. · 2022 · 2 generations on2descendants
- K222692BriefCaseAidoc Medical, Ltd. · 2022 · cites it directly1descendant
- K240612Cina-VCFAvicenna.Ai · 2024 · 2 generations on0descendants
- K230074Rapid Aneurysm Triage and NotificationIschemaview, Inc. · 2023 · 3 generations on0descendants
View 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) | K192901 | HealthVCF | Zebra Medical Vision, Ltd. | 2020 | — |
| +1 | K193271 | uAI EasyTriage-Rib | Shanghai United Imaging Intelligence Co., Ltd. | 2021 | — |
| +2 | K213319 | Viz ANEURYSM, Viz ANX | Viz. Ai, Inc. | 2022 | — |
| +1 | K222692 | BriefCase | Aidoc Medical, Ltd. | 2022 | — |
| +2 | K240612 | Cina-VCF | Avicenna.Ai | 2024 | — |
| +3 | K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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…I. Predicate Device: The HealthVCF 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? (6)
2 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 2 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K193271 (Shanghai United Imaging Intelligence Co., Ltd., 2021) has gone furthest, with 3 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?
HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. These flags are…
Read the full statement (140 words)
HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS). HealthVCF does not send a proactive alert directly to the user.
HealthVCF does not provide diagnostic information beyond triage and prioritization, it does not remove cases from the radiology worklist, and should not be used in place of full patient evaluation, or relied upon to make or confirm diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192901: HealthVCF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192901
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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