BriefCase
K190072Aidoc Medical, Ltd. · cleared 2019-04-15 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT and CTPA images.”
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation.”
Validation studies (2)
Retrospective clinical
n=2,803 cases · 1 site(s)
endpoints: Specificity; Sensitivity
Retrospective clinical
n=184 cases · 3 site(s)
endpoints: software's performance in identifying CTPAS containing pulmonary embolism; potential clinical benefit of worklist prioritization for true positive PE cases
Reported performance (4 observations)
source quote (p.7)
“Specifically, sensitivity was observed to be 90.6% (95% CI: 82.2%-95.9%)”
source quote (p.7)
“and specificity was observed to be 89.9% (95% CI: 82.2%-95.1%).”
source quote (p.7)
“The BriefCase time-to-notification for PE was 3.9 minutes (95% CI: 3.7-4.1).”
source quote (p.8)
“of care time-to-exam-open was much longer (64.1 minutes: 95% CI 36.6-91.5).”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253578 (decision 2026-02-26) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253578
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251195 (decision 2026-01-27) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251195
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252970 (decision 2026-01-07) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-triage CT Body") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252970
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253265 (decision 2025-11-06) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253265
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251406 (decision 2025-05-30) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251406
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250248 (decision 2025-02-14) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250248
- …and 26 more.
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).