BriefCase-Triage
K251195Aidoc Medical , Ltd. · cleared 2026-01-27 · product code QAS · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.6)
“Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM compliant CT scanners, PACS, and radiology workstations.”
source quote (p.13)
“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)
Retrospective clinical
n=544 cases · 6 site(s)
endpoints: sensitivity; specificity; BriefCase-Triage time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)
Reported performance (7 observations)
source quote (p.10)
“For the primary endpoint, sensitivity was 87.8% (95% CI: 83.1%, 91.6%) and specificity was 91.6% (95% CI: 87.9%, 94.5%), meeting the study’s primary endpoint.”
source quote (p.10)
“For the primary endpoint, sensitivity was 87.8% (95% CI: 83.1%, 91.6%) and specificity was 91.6% (95% CI: 87.9%, 94.5%), meeting the study’s primary endpoint.”
source quote (p.11)
“NPV was 98.9% (95% CI: 98.4%-99.2%) and PPV was 47.6% (95% CI: 38.4%-57.1%).”
source quote (p.11)
“NPV was 98.9% (95% CI: 98.4%-99.2%) and PPV was 47.6% (95% CI: 38.4%-57.1%).”
source quote (p.11)
“PLR was 10.5 (95% CI: 7.2-15.3) and NLR was 0.13 (95% CI: 0.1-0.19).”
source quote (p.11)
“PLR was 10.5 (95% CI: 7.2-15.3) and NLR was 0.13 (95% CI: 0.1-0.19).”
source quote (p.10)
“The BriefCase-Triage mean timeto-notification for the subject BA triage was 44.8 seconds (95% CI: 41.4-48.2).”
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
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).