# K231871: Radify Triage

- Pathway: 510(k) (Abbreviated)
- Applicant: Envisionit Deepai, Ltd.
- Decided: Jan 17, 2024 after 205 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211733: Lunit INSIGHT CXR Triage, Lunit, Inc. (2021) Summary page 4.

## Indications for use
RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RADIFY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, RADIFY® Triage does not send a proactive alert directly to the appropriately trained medical specialists. The product is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The device does not remove the cases from the queue and does not flag the condition as being absent.

Source page: https://510kreport.com/device/K231871
Methodology: https://510kreport.com/methodology