# K231767: Annalise Enterprise CTB Triage Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Annalise-Ai Pty, Ltd.
- Decided: Sep 22, 2023 after 98 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN170073 (2018). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223240: Annalise Enterprise CTB Triage Trauma, Annalise-Ai Pty, Ltd. (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K231767
Methodology: https://510kreport.com/methodology