510(k) · Cleared
ClearedHealthCXR
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 Nov 26, 2019 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 92-day review. Its family tree reaches back 3 generations to 2018. 9 later devices descend from it.
- Decided
- Nov 26, 2019
- Review
- 92 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- This deviceK192320 HealthCXRZebra Medical Vision, Ltd. · 2019
- Descendant · cites it directly · 7 of its ownK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK230899 qXR-PTX-PEQure.Ai Technologies · 2023
- Descendant · 2 generations on · 0 of its ownK253751 CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026
- Descendant · 2 generations on · 0 of its ownK243808 Rayvolve PTX-PEAZmed · 2025
- Descendant · 3 generations on · 0 of its ownK241439 VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K211733Lunit INSIGHT CXR TriageLunit, Inc. · 2021 · cites it directly7descendants
- K230899qXR-PTX-PEQure.Ai Technologies · 2023 · 2 generations on1descendant
- K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026 · 2 generations on0descendants
- K243808Rayvolve PTX-PEAZmed · 2025 · 2 generations on0descendants
- K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| 0 (this device) | K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019 | — |
| +1 | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| +2 | K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023 | — |
| +2 | K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
| +2 | K243808 | Rayvolve PTX-PE | AZmed | 2025 | — |
| +3 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K190362 | HealthPNXSummary page 4…. Predicate Device: The HealthCXR device is substantially equivalent to the following device: Proprietary Name HealthPNX Premarket Notification K190362 Classification Name Radiological Computer-Assisted Prioritization Software Regulation Number 21 CFR 892… | 2019 |
What descends from it? (9)
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 1 year and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211733 (Lunit, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K190362.
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?
The Zebra HealthCXR device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion in the medical care environment. HealthCXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthCXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pleural effusion or otherwise preclude clinical assessment of X-Ray cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192320: HealthCXR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192320
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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