510(k) · Cleared
ClearedAnnalise Enterprise
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Annalise-Ai · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Apr 23, 2025 as substantially equivalent to K222179 (Annalise-Ai Pty, Ltd., 2023) after a 35-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Apr 23, 2025
- Review
- 35 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN170073 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 5 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 4 generations backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- 3 generations backK191556 Red DotBehold.Ai Technologies Limited · 2020
- 2 generations backK213941 Annalise Enterprise CXR Triage PneumothoraxAnnalise-Ai · 2022
- 1 generation backK222179 Annalise Enterprise CXR Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- This deviceK250831 Annalise EnterpriseAnnalise-Ai · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −5 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −4 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| −3 | K191556 | Red Dot | Behold.Ai Technologies Limited | 2020 | — |
| −2 | K213941 | Annalise Enterprise CXR Triage Pneumothorax | Annalise-Ai | 2022 | — |
| −1 | K222179 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| 0 (this device) | K250831 | Annalise Enterprise | Annalise-Ai | 2025 | — |
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 |
|---|---|---|---|
| * | K222179 | Annalise Enterprise CXR Triage TraumaSummary page 6…ode QFM, QAS* III. PREDICATE DEVICE Manufacturer Name Annalise-AI Device Name Annalise Enterprise CXR Triage Trauma 510(k) reference K222179 Classification Name Radiological computer aided triage and notification software (21CFR892.2080) Reg… | 2023 |
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 7 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
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. 2025, 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?
Intended context: Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: * pleural effusion* [1] * pneumoperitoneum* [2] * pneumothorax * tension pneumothorax * vertebral compression fracture* [3] *See additional information below. The device analyzes studies using an artificial intelligence algorithm to identify findings. It…
Read the full statement (343 words)
Intended context:
Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings:
* pleural effusion* [1]
* pneumoperitoneum* [2]
* pneumothorax
* tension pneumothorax
* vertebral compression fracture* [3]
*See additional information below.
The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage.
The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings.
Its results are not intended:
* to be used on a standalone basis for clinical decision making
» to rule out specific findings, or otherwise preclude clinical assessment of chest X-ray studies
Intended modality:
Annalise Enterprise identifies suspected findings in digitized (CR) or digital (DX) chest X-ray studies.
Intended user:
The device is intended to be used by trained clinicians who are qualified to interpret chest X-ray studies as part of their scope of practice.
Intended patient population:
The intended population is patients who are 22 years or older.
Additional information:
The following additional information relates to the findings listed above:
[1] Pleural effusion
» specificity may be reduced in the presence of scarring and/or pleural thickening
« standalone performance evaluation was performed on a dataset that included supine and erect positioning
« use of this device with prone positioning may result in differences in performance
[2] Pneumoperitoneum
« standalone performance evaluation was performed on a dataset that included supine and erect positioning where most cases were of unilateral right-sided and bilateral pneumoperitoneum
» use of this device with prone positioning and for unilateral left-sided pneumoperitoneum may result in differences in performance
[3] Vertebral compression fracture
* intended for prioritization or triage of worklists of Bone Health and Fracture Liaison Service program clinicians
« standalone performance evaluation 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250831: Annalise Enterprise.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250831
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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