510(k) · Cleared
ClearedHealthPPT
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 Dec 15, 2021 as substantially equivalent to K193300 (Radlogics, Inc., 2020) after a 187-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Dec 15, 2021
- Review
- 187 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 3 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 2 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 1 generation backK193300 AIMI-Triage CXR PTXRadlogics, Inc. · 2020
- This deviceK211803 HealthPPTZebra Medical Vision, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K193300 | AIMI-Triage CXR PTXSummary page 4…II. Predicate Device: The HealthPPT device is substantially equivalent to the following device: Proprietary Name AIMI-Triage CXR PTX Premarket Notification K193300 Classification Name Radiological Computer-Assisted Prioritization Software Regulation Number 21 CFR 892.2080 Produc… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K193300.
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. 2021, 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 HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT 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. HealthPPT is not intended to direct attention to anomalies…
Read the full statement (138 words)
The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment. HealthPPT 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. HealthPPT is not intended to direct attention to anomalies other than pneumoperitoneum. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumoperitoneum or otherwise preclude clinical assessment of X-Ray cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211803 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211803: HealthPPT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211803
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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