# K213886: BriefCase

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Apr 26, 2022 after 134 days
- Product code: QAS (Radiological Computer-Assisted Triage And Notification Software)
- 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). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203508: BriefCase, Aidoc Medical, Ltd. (2020) Summary page 4.

## Most influential descendants
- K250248: BriefCase-Triage (2025), 0 descendants of its own
- K233968: CINA-iPE (2024), 0 descendants of its own

## Indications for use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 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 cases of incidental Pulmonary Embolism (iPE) pathologies. The device is intended to be used on single- energy exams only. 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 presented with notifications 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/K213886
Methodology: https://510kreport.com/methodology