# K221552: EFAI ChestSuite XR Pneumothorax Assessment System

- Pathway: 510(k) (Traditional)
- Applicant: Ever Fortune.Ai, Co., Ltd.
- Decided: Nov 8, 2022 after 161 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.
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)
- K191556: Red Dot, Behold.Ai Technologies Limited (2020) Summary page 4.

## Indications for use
EFAI PNXXR is a software workflow tool designed to aid the clinical assessment of adult (22 years of age or older) Posteroanterior (PA) view Chest X-Ray cases with features suggestive of pneumothorax in the medical care environment. EFAI PNXXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI PNXXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumothorax or otherwise preclude clinical assessment of X-Ray cases.

Source page: https://510kreport.com/device/K221552
Methodology: https://510kreport.com/methodology