BriefCase
K190896Aidoc Medical, Ltd. · cleared 2019-05-31 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and is comprised of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application.”
source quote (p.8)
“Both devices are software packages with similar technological characteristics and principles of operation, incorporating deep learning AI algorithms that process images, and software to send notifications and unannotated compressed preview images to the radiologists' workstation.”
Validation studies (1)
Retrospective clinical
n=186 cases · 3 site(s)
endpoints: evaluate the software's performance in identifying CTs containing cervical spine fracture; Briefcase's potential clinical benefit of worklist prioritization for true positive CSF cases
Reported performance (6 observations)
source quote (p.7)
“Specifically, sensitivity was 91.7% (95% CI: 82.7%, 96.9%)”
source quote (p.7)
“and specificity was 88.6% (95% CI: 81.2%, 93.8%).”
source quote (p.8)
“NPV was 99.0% (95% CI: 98.3%-99.8%)”
source quote (p.8)
“and PPV was 47.2% (95% CI: 31.3%-57.5%).”
source quote (p.7)
“The BriefCase time-to-notification for CSF was 3.9 minutes (95% CI: 3.8-4.1).”
source quote (p.7)
“In contrast, standard of care time-to-exam-open was much longer (58.4 minutes: 95% CI 45.3-71.4).”
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 25 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).