510(k) · Cleared
ClearedHealthPNX
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 6, 2019 as substantially equivalent to K183285 (Curemetrix, Inc., 2019) after an 80-day review. Its family tree reaches back 2 generations to 2018. 23 later devices descend from it.
- Decided
- May 6, 2019
- Review
- 80 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 23 later devices descend from it, 6 citing it directly.
- Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 1 generation backK183285 cmTriageCuremetrix, Inc. · 2019
- This deviceK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- Descendant · cites it directly · 9 of its ownK192320 HealthCXRZebra Medical Vision, Ltd. · 2019
- Descendant · cites it directly · 8 of its ownK183182 Critical Care SuiteGe Medical Systems, LLC · 2019
- Descendant · 2 generations on · 7 of its ownK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- Descendant · cites it directly · 6 of its ownK191556 Red DotBehold.Ai Technologies Limited · 2020
- Descendant · 2 generations on · 3 of its ownK213941 Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K192320HealthCXRZebra Medical Vision, Ltd. · 2019 · cites it directly9descendants
- K183182Critical Care SuiteGe Medical Systems, LLC · 2019 · cites it directly8descendants
- K211733Lunit INSIGHT CXR TriageLunit, Inc. · 2021 · 2 generations on7descendants
- K191556Red DotBehold.Ai Technologies Limited · 2020 · cites it directly6descendants
- K213941Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022 · 2 generations on3descendants
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) | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| +1 | K192320 | HealthCXR | Zebra Medical Vision, Ltd. | 2019 | — |
| +1 | K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019 | — |
| +2 | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| +1 | K191556 | Red Dot | Behold.Ai Technologies Limited | 2020 | — |
| +2 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K183285 | cmTriage Cleared while this submission was under review Summary page 4…edicate Device The HealthPNX device is substantially equivalent to the following device: Proprietary Name cmTriage Premarket Notification K183285 Classification Name Radiological Computer-Assisted Prioritization Software Regulation Number 21 C… | 2019 |
What descends from it? (23)
See all 236 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 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K192320 (Zebra Medical Vision, Ltd., 2019) has gone furthest, with 9 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. 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 Pneumothorax device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. HealthPNX 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. HealthPNX 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 Pneumothorax or otherwise preclude clinical assessment of X-Ray cases.
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/K190362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190362: HealthPNX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190362
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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