# K222268: Annalise Enterprise CXR Triage Trauma

- Pathway: 510(k) (Traditional)
- Applicant: Annalise-Ai Pty, Ltd.
- Decided: Mar 28, 2023 after 243 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- 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: 5 generations back to DEN170073 (2018). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213941: Annalise Enterprise CXR Triage Pneumothorax, Annalise-Ai (2022) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K222268
Methodology: https://510kreport.com/methodology