BriefCase-Triage: CARE Multi-triage CT Body

K252970

Aidoc Medical , Ltd. · cleared 2026-01-07 · 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.”

Algorithmlocked artificial intelligence algorithm fine tuned from a foundation model

source quote (p.11)

“Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”

Adaptive (vs locked)No

source quote (p.11)

“Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.27)

“Cybersecurity has been incorporated into the software development lifecycle in alignment with Section 524B of the FD&C Act and FDA cybersecurity guidance.”

Validation studies (1)

Standalone

n=1,769 scans · 6 site(s)

endpoints: pre-specified standalone performance goal (PG) of area under the curve (AUC) > 0.95 for the finding level receiver operating characteristic (ROC) curve; sensitivity; specificity; BriefCase 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 (4 observations)

sensitivity0.986CI 95.1%-99.8%

source quote (p.12)

“98.6% 95.1%-99.8%”

specificity0.985CI 94.7%-99.8%

source quote (p.12)

“98.5% 94.7%-99.8%”

aurocas written: “auc”0.999CI 99.7-100

source quote (p.12)

“99.9 99.7-100”

time_to_resultas written: “mean time-to-notification”45CI 43.4-46.5

source quote (p.14)

“The Briefcase-Triage mean time-to-notification for the subject device triage was 45 seconds (95% CI: 43.4-46.5).”

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) 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

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).