BriefCase
K230020Aidoc Medical, Ltd. · cleared 2023-02-01 · product code QFM · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast) images, in adults or transitional adolescents aged 18 and older.”
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation.”
Validation studies (1)
Retrospective clinical
n=308 cases · 5 site(s)
endpoints: area under the curve (AUC) > 0.95 for the study level receiver operating characteristic (ROC) curve; 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 (8 observations)
source quote (p.8)
“Sensitivity was 98.08% (95% CI: 93.23%, 99.77%)”
source quote (p.8)
“Specificity was 93.14% (95% CI: 88.75%, 96.20%)”
source quote (p.8)
“AUC was 0.98 (95% CI: 0.966, 0.994)”
source quote (p.9)
“NPV was 99.8% (95% CI: 99.1% - 99.9%)”
source quote (p.9)
“PPV was 61.4% (95% CI: 48.9% - 72.5%).”
source quote (p.9)
“PLR was 14.2912 (95% CI: 8.614 - 23.710)”
source quote (p.9)
“NLR was 0.0206 (95% CI: 0.005 - 0.082).”
source quote (p.8)
“The BriefCase mean time-to-notification for the subject RibFx triage was 70.1 seconds (95% CI: 64.9-75.4).”
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
- 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 9 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).