510(k) · Cleared
ClearedAnnalise Enterprise CXR Triage Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Annalise-Ai Pty, Ltd. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Mar 28, 2023 as substantially equivalent to K213941 (Annalise-Ai, 2022) after a 243-day review. Its family tree reaches back 5 generations to 2018.
- Decided
- Mar 28, 2023
- Review
- 243 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 5 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 4 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 3 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 2 generations backK191556 Red DotBehold.Ai Technologies Limited · 2020
- 1 generation backK213941 Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022
- This deviceK222268 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −4 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −3 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −2 | K191556 | Red Dot | Behold.Ai Technologies Limited | 2020 | — |
| −1 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022 | — |
| 0 (this device) | K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K213941 | Annalise Enterprise CXR Triage PneumothoraxSummary page 4…. PREDICATE DEVICE Manufacturer Name Annalise-AI Pty Ltd Device Name Annalise Enterprise CXR Triage Pneumothorax 510(k) reference K213941 Classification Name Radiological computer aided triage and notification software (21CFR892.… | 2022 |
| † | K192901 | HealthVCF | 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 5 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K213941.
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. 2023, 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?
Annalise Enterprise CXR Triage Trauma is a software workflow tool designed to aid the clinical assessment of adult chest X-ray cases with features suggestive of vertebral compression fracture in the medical care environment. The device analyzes cases using an artificial intelligence algorithm to identify findings. It makes case-level output available to a PACS or RIS for worklist prioritization or triage intended for clinicians in Bone Health and…
Read the full statement (180 words)
Annalise Enterprise CXR Triage Trauma is a software workflow tool designed to aid the clinical assessment of adult chest X-ray cases with features suggestive of vertebral compression fracture in the medical care environment.
The device analyzes cases using an artificial intelligence algorithm to identify findings. It makes case-level output available to a PACS or RIS for worklist prioritization or triage intended for clinicians in Bone Health and Fracture Liaison Service programs.
The device is intended to be used by trained clinicians who are qualified to interpret chest X-rays as part of their scope of practice.
The device is not intended to direct attention to specific portions of an image or to anomalies other than vertebral compression fracture.
Its results are not intended to be used on a standalone basis for clinical decision making nor is it intended to rule out specific critical findings, or otherwise preclude clinical assessment of X-ray cases.
Standalone performance evaluation of the device was performed on a dataset that included only erect positioning. Use of this device with supine positioning may result in differences in performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222268 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222268: Annalise Enterprise CXR Triage Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222268
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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