# K213941: Annalise Enterprise CXR Triage Pneumothorax

- Pathway: 510(k) (Traditional)
- Applicant: Annalise-Ai
- Decided: Feb 24, 2022 after 70 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: 4 generations back to DEN170073 (2018). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191556: Red Dot, Behold.Ai Technologies Limited (2020) Summary page 4.

## Most influential descendants
- K222179: Annalise Enterprise CXR Triage Trauma (2023), 1 descendant of its own
- K250831: Annalise Enterprise (2025), 0 descendants of its own
- K222268: Annalise Enterprise CXR Triage Trauma (2023), 0 descendants of its own

## Indications for use
The device is designed to aid the clinical assessment of adult chest x-ray cases with features suggestive of pneumothorax and tension pneumothorax in the medical care environment. The device analyses 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. 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 pneumothorax and tension pneumothorax. Its results are not intended to be used on a standalone basis for clinical decision making nor it is intended to rule out pneumothorax or tension pneumothorax, or otherwise preclude clinical assessment of X-ray cases.

Source page: https://510kreport.com/device/K213941
Methodology: https://510kreport.com/methodology