# K214043: BriefCase

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Mar 14, 2022 after 81 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
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect positive cases with Pneumothorax (Ptx) findings. BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is notified for suspect cases. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of BriefCase are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.

Source page: https://510kreport.com/device/K214043
Methodology: https://510kreport.com/methodology