| K-number | K251195 |
| Device name | BriefCase-Triage |
| Applicant | Aidoc Medical , Ltd. |
| Product code | QAS |
| Device class | Class II |
| Decision date | Jan 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.2080 |
BriefCase-Triage is an artificial intelligence software that analyzes contrast-enhanced CT images of the brain to detect and notify users of suspected brain aneurysms (3.0 mm or larger) in adults aged 18 and older. The device operates in parallel with standard clinical workflow, providing compressed preview images and notifications to assist radiologists with triage and prioritization, but does not alter original images or remove cases from the standard reading queue.
Both the subject and predicate devices are deep learning AI algorithms for radiological triage and notification. The subject device differs in: (1) expanded indications to include general contrast-enhanced CT (not just CTA), (2) lower aneurysm detection threshold (3.0 mm vs. 5 mm), (3) three additional operating points for enhanced specificity, and (4) revised software architecture separating the image communication platform from the algorithm module.
Not stated in this summary.
The subject BriefCase-Triage for BA is substantially equivalent to the predicate (K213721) because both are AI-based triage software that operate in parallel to standard care, provide unannotated compressed preview images and prioritization alerts, neither remove or de-prioritize cases, and achieve comparable time-to-notification (44.8 seconds vs. 252 seconds). The subject device met primary endpoints of 87.8% sensitivity and 91.6% specificity (both exceeding 80% goal), and the technological differences do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov