BriefCase
K214043Aidoc Medical, Ltd. · cleared 2022-03-14 · product code QFM · 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 Chest X-Ray images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect positive cases with Pneumothorax (Ptx) findings.”
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and flag suspect cases on a standalone desktop application in parallel to the ongoing standard of care image interpretation.”
Validation studies (1)
Retrospective clinical
n=619 cases · 5 site(s)
endpoints: evaluate the software's performance in identifying Pneumothorax in chest X-ray exams
Reported performance (7 observations)
source quote (p.9)
“Sensitivity was 94.2% (95% CI: 89.9%, 97.8%)”
source quote (p.9)
“Specificity was 90.8% (95% CI: 88.1%, 93.1%).”
source quote (p.9)
“AUC was 0.969 (95% CI: 0.954, 0.985)”
source quote (p.9)
“NPV was 99.3% (95% CI: 98.6%-99.6%)”
source quote (p.9)
“PPV was 53.3 % (95% CI: 46.2%-60.3%).”
source quote (p.9)
“PLR was 10.28% (95% CI: 7.73%-13.67%)”
source quote (p.9)
“NLR was 0.06 % (95% CI: 0.03%-0.12%).”
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 19 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).