BriefCase, RIB Fractures Triage (RibFx)
K202992Aidoc Medical, Ltd. · cleared 2021-04-14 · product code QFM · 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.5)
“Both devices are artificial intelligence deep-learning algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.”
source quote (p.4)
“DICOM images are received, saved, filtered and de-identified before processing.”
Validation studies (1)
Retrospective clinical
n=279 cases · 3 site(s)
endpoints: software's performance in identifying three or more acute rib fractures; potential clinical benefit of worklist prioritization for true positive RibFx cases by comparing time-to-exam-open to time-to-notification
Reported performance (7 observations)
source quote (p.8)
“Sensitivity was 96.7% (95% CI: 90.6%, 99.4%)”
source quote (p.8)
“specificity was 90.4% (95% CI: 85.2%, 94.3%).”
source quote (p.8)
“AUC was 0.976 (95% CI: 0.960, 0.991).”
source quote (p.9)
“NPV was 99.6% (95% CI: 99.2%-100.0%)”
source quote (p.9)
“PPV was 52.9% (95% CI: 39.1%-62.1%).”
source quote (p.8)
“The standard of care time-to-exam-open (89.4 minutes: 95% CI: 56.0-122.7; Median 66.0, IQR 50.7)”
source quote (p.8)
“the parallel time-to-notification of the BriefCase device (4.2 minutes, 95% CI: 3.9-4.5; Median 4.2, IQR 1.8)”
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) 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) 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243548 (decision 2024-12-11) 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:K243548
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242837 (decision 2024-10-18) 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:K242837
- …and 13 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).