# K253578: BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

- Pathway: 510(k) (Traditional)
- Applicant: Aidoc Medical, Ltd.
- Decided: Feb 26, 2026 after 101 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: 6 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)
- K251406: BriefCase-Triage, Aidoc Medical, Ltd. (2025) Summary page 5.

## Indications for use
BriefCase-Triage: CARE (Clinical Al Reasoning Engine) Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is a radiological computer aided triage and notification software indicated for use in the analysis of contrast and non-contrast CT images of the chest, abdomen, or chest/abdomen, 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 communicating suspected positive findings, per study, of: Pneumothorax; Pericardial effusion; Large aortic aneurysm Shoulder Fracture or Dislocation The device flags cases with at least one suspected finding to assist with triage/prioritization of medical images. The device will provide a flag for each suspected finding within this study. A preview image will be provided for each distinct suspected finding. BriefCase-Triage uses a foundation model-based artificial intelligence (Al) system to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images for each suspected finding that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical images and is not intended to be used as a diagnostic device. The results of BriefCase-Triage 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/K253578
Methodology: https://510kreport.com/methodology