# K221241: DrAid for Radiology v1

- Pathway: 510(k) (Traditional)
- Applicant: Vinbrain Joint Stock Company
- Decided: Sep 1, 2022 after 125 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190362: HealthPNX, Zebra Medical Vision, Ltd. (2019) Summary page 5.

## Indications for use
The DrAidTM for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pneumothorax in medical care environment. DrAidTM analyzes cases using an artificial intelligence algorithm to features suggestive of suspected findings. It makes case-level output available to a PACS for worklist prioritization or triage. As a passive notification for prioritization-only software tool with standard of care workflow, DrAidTM does not send a proactive alert directly to appropriately trained medical specialists. DrAidTM 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/K221241
Methodology: https://510kreport.com/methodology