BriefCase-Triage
K253265Aidoc Medical , Ltd. · cleared 2025-11-06 · product code QAS · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT 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 suspected positive findings of Intra-abdominal free gas (IFG) pathologies.”
source quote (p.4)
“BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with the detected findings in parallel to the ongoing standard of care image interpretation. The algorithm was trained during software development on images of the pathology. As is customary in the field of machine learning, deep learning algorithm development consisted of training on labeled ("tagged") images.”
source quote (p.17)
“Cybersecurity has been incorporated into the software development lifecycle in alignment with Section 524B of the FD&C Act and FDA cybersecurity guidance. Aidoc has implemented a risk-based approach to cybersecurity, including secure design practices, vulnerability assessments, a Software Bill of Materials (SBOM), and penetration testing. These efforts support the safety, effectiveness, and resilience of the software against cybersecurity threats.”
Validation studies (1)
Retrospective clinical
n=394 cases · 6 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 (4 observations)
source quote (p.10)
“Sensitivity was 94.2% (95% CI: 89.6%, 97.2%)”
source quote (p.10)
“Specificity was 94.6% (95% CI: 90.7%, 97.2%)”
source quote (p.10)
“The Briefcase-Triage mean time-to-notification for the subject IFG triage was 10.4 seconds (95% CI: 10.1-10.8).”
source quote (p.10)
“The time-to-notification for the predicate IFG was 264.4 seconds (95% CI: 222-300).”
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
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).