BriefCase
K193298Aidoc Medical, Ltd. · cleared 2020-06-19 · 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.9)
“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.”
source quote (p.9)
“Both devices operate in parallel to the standard of care workflow in the sense that they do not change the original image, do not provide any marking on the output preview, and do not remove images from the standard of care FIFO queue, thus not disturbing standard interpretation of the images by the attending radiologists.”
Validation studies (1)
Retrospective clinical
n=184 cases · 3 site(s)
endpoints: evaluate the software's performance in identifying abdominal CTs containing Intra-abdominal Free Gas; worklist prioritization for true positive IFG cases
Reported performance (6 observations)
source quote (p.7)
“Specifically, sensitivity was 91.0% (95% CI: 81.5%, 96.7%)”
source quote (p.7)
“and specificity was 88.9% (95% CI: 81.7%, 94.0%).”
source quote (p.8)
“Negative Predictive Value 110 99.7% 99.5% 99.9%”
source quote (p.8)
“Positive Predictive Value 74 20.2% 7.7% 26.3%”
source quote (p.9)
“NLR 184 0.1 0.0 0.2”
source quote (p.9)
“PLR 184 8.2 4.9 13.8”
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 23 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).