BriefCase
K213721Aidoc Medical, Ltd. · cleared 2022-03-21 · 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”
source quote (p.7)
“Artificial intelligence Deep-learning algorithm with database of images.”
Validation studies (1)
Retrospective clinical
n=268 cases · 5 site(s)
endpoints: evaluate the software's performance in identifying head CTs (with and without contrast) containing Brain Aneurysm; Briefcase's potential clinical benefit of worklist prioritization for true positive BA cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for BA
Reported performance (8 observations)
source quote (p.8)
“Specifically, sensitivity was 88.5% (95% CI: 80.4%, 94.1%)”
source quote (p.8)
“and specificity was 89.5% (95% CI: 84.0%, 93.7%).”
source quote (p.9)
“NPV was 98.9% (95% CI: 98.3%-99.6%)”
source quote (p.9)
“PPV was 42.4% (95% CI: 30.0%-51.7%)”
source quote (p.9)
“PLR was 8.46% (95% CI: 5.43%-13.18%)”
source quote (p.9)
“NLR was 0.13 (95% CI: 0.07%-0.22%)”
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)
“time-to-notification metric 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) 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 18 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).