BriefCase-Triage

K251406

Aidoc Medical, Ltd. · cleared 2025-05-30 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Briefcase-Triage is a radiological computer-assisted triage and notification software device. The software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.”

Algorithmartificial intelligence, deep-learning algorithms

source quote (p.6)

“Both devices are artificial intelligence, deep-learning algorithms incorporated in software components for use with DICOM compliant CT scanners, PACS, and radiology workstations.”

Adaptive (vs locked)No

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=509 cases · 5 site(s)

endpoints: sensitivity; specificity; Briefcase-Triage time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (8 observations)

sensitivity0.927CI 88.2%, 95.8%

source quote (p.10)

“Sensitivity was 92.7% (95% CI: 88.2%, 95.8%)”

specificity0.928CI 89.2%, 95.4%

source quote (p.10)

“Specificity was 92.8% (95% CI: 89.2%, 95.4%).”

npvas written: “NPV”0.998CI 99.7%- 99.9%

source quote (p.11)

“NPV was 99.8% (95% CI: 99.7%- 99.9%)”

ppvas written: “PPV”0.247CI 18.0%- 33.0%

source quote (p.11)

“PPV was 24.7% (95% CI: 18.0%- 33.0%).”

ppvas written: “PLR”12.8CI 8.5- 19.2

source quote (p.11)

“PLR was 12.8 (95% CI: 8.5- 19.2)”

npvas written: “NLR”0.08CI 0.05-0.13

source quote (p.11)

“NLR was 0.08 (95% CI: 0.05-0.13).”

time_to_resultas written: “Briefcase-Triage mean time-to-notification”10.7CI 10.5-10.9

source quote (p.10)

“The Briefcase-Triage mean time-to-notification for the subject AD triage was 10.7 seconds (95% CI: 10.5-10.9).”

time_to_resultas written: “Predicate AD time-to-notification”38CI 35.5-40.4

source quote (p.10)

“The time-to-notification for the predicate AD was 38.0 seconds (95% CI: 35.5-40.4).”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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

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).