510(k) · Cleared
ClearedAnnalise Enterprise CTB Triage Trauma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Annalise-Ai Pty, Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software
Cleared on Sep 22, 2023 as substantially equivalent to K223240 (Annalise-Ai Pty, Ltd., 2023) after a 98-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Sep 22, 2023
- Review
- 98 days
- Class
- Class II
- Product code
- QAS
- 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 backK180647 BriefCaseAidoc Medical, Ltd. · 2018
- 2 generations backK211179 InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd. · 2021
- 1 generation backK223240 Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
- This deviceK231767 Annalise Enterprise CTB Triage TraumaAnnalise-Ai Pty, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −3 | K180647 | BriefCase | Aidoc Medical, Ltd. | 2018 | — |
| −2 | K211179 | InferRead CT Stroke.AI | Infervision Medical Technology Co., Ltd. | 2021 | — |
| −1 | K223240 | Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty, Ltd. | 2023 | — |
| 0 (this device) | K231767 | Annalise Enterprise CTB 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 QAS? 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 QAS device
- #1 K203508 BriefCasescore 25.5 · 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 |
|---|---|---|---|
| * | K223240 | Annalise Enterprise CTB Triage TraumaSummary page 5…e QAS III. PREDICATE DEVICE Manufacturer Name Annalise-AI Pty Ltd Device Name Annalise Enterprise CTB Triage Trauma 510(k) reference K223240 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 5 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K223240.
How does its category compare?
All QAS devicesQAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QAS
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QAS
101in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QAS
No recall names QAS since 2007.
Adverse event reports per year · QAS
No MAUDE report names QAS 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 | 3 | — | 0 | 0 |
| 2019 | 5 | 111 | 0 | 0 |
| 2020 | 12 | 112 | 0 | 0 |
| 2021 | 5 | 86 | 0 | 0 |
| 2022 | 15 | 116 | 0 | 0 |
| 2023 | 11 | 98 | 0 | 0 |
| 2024 | 12 | 136 | 0 | 0 |
| 2025 | 15 | 101 | 0 | 0 |
| 2026 | 11 | 104 | 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 finding: vasogenic edema The device analyzes studies using an artificial intelligence algorithm to identify the finding. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device is not intended…
Read the full statement (171 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 finding:
vasogenic edema
The device analyzes studies using an artificial intelligence algorithm to identify the finding. 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 the suspected finding.
Its results are not intended:
* to be used on a standalone basis for clinical decision making
* to rule out a specific finding, or otherwise preclude clinical assessment of CTB studies
Intended modality:
Annalise Enterprise identifies the suspected finding in non-contrast brain CT studies.
Intended user:
The device is intended to be used by trained clinicians who, as part of their scope of practice, are qualified to interpret brain CT studies.
Intended patient population:
The intended population is patients who are 22 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231767: Annalise Enterprise CTB Triage Trauma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231767
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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