BriefCase-Triage

K241727

Aidoc Medical, Ltd. · cleared 2024-07-12 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“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.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM compliant CT scanners, PACS, and radiology workstations.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=499 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 (14 observations)

sensitivity94.39CI 90.41%, 97.07%
source quote (p.8)
“Sensitivity was 94.39% (95% CI: 90.41%, 97.07%)”
specificity94.39CI 91.04%, 96.67%
source quote (p.8)
“Specificity was 94.39% (95% CI: 91.04%, 96.67%).”
npvas written: “Negative Predictive Value (NPV)”98.96CI 98.21%- 99.4%
source quote (p.9)
“NPV was 98.96% (95% CI: 98.21%- 99.4%)”
ppvas written: “Positive Predictive Value (PPV)”74.79CI 64.80%- 82.7%
source quote (p.9)
“PPV was 74.79% (95% CI: 64.80%- 82.7%).”
time_to_resultas written: “Briefcase-Triage mean time-to-notification”26.42CI 25.3-27.54
source quote (p.9)
“The Briefcase-Triage mean time-to-notification for the subject PE triage was 26.42 seconds (95% CI: 25.3-27.54).”
time_to_resultas written: “Predicate PE time-to-notification”78CI 73.6-82.3
source quote (p.9)
“The time-to-notification for the predicate PE was 78 seconds (95% CI 73.6-82.3).”
sensitivityas written: “AOP1 Sensitivity”99.53CI 97.42%- 99.99%
source quote (p.11)
“Sensitivity was 99.53% (95% CI: 97.42%- 99.99%)”
specificityas written: “AOP1 Specificity”86.67CI 82.16%-90.39%
source quote (p.11)
“Specificity was 86.67% (95% CI: 82.16%-90.39%).”
sensitivityas written: “AOP2 Sensitivity”97.66CI 94.63%-99.24%
source quote (p.11)
“Sensitivity was 97.66% (95% CI: 94.63%-99.24%)”
specificityas written: “AOP2 Specificity”91.93CI 88.14%-94.82%
source quote (p.11)
“Specificity was 91.93% (95% CI: 88.14%-94.82%.”
sensitivityas written: “AOP3 Sensitivity”91.59CI 87.03%- 94.94%
source quote (p.11)
“Sensitivity was 91.59% (95% CI: 87.03%- 94.94%)”
specificityas written: “AOP3 Specificity”96.49CI 93.64%-98.3%
source quote (p.11)
“Specificity was 96.49% (95% CI: 93.64%-98.3%).”
sensitivityas written: “AOP4 Sensitivity”85.98CI 80.6%-90.34%
source quote (p.11)
“Sensitivity was 85.98% (95% CI: 80.6%-90.34%)”
specificityas written: “AOP4 Specificity”98.25CI 95.95%-99.43%
source quote (p.11)
“Specificity was 98.25% (95% CI: 95.95%-99.43%).”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
8
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

  • 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 2 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K241727