BriefCase-Triage

K232751

Aidoc Medical, Ltd. · cleared 2023-10-30 · 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. 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.6)
“All 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=328 cases · 6 site(s)

endpoints: sensitivity; specificity; time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (7 observations)

sensitivity89.2CI 95% CI: 82.5%, 93.9%
source quote (p.10)
“Sensitivity was 89.2% (95% CI: 82.5%, 93.9%)”
specificity94.5CI 95% CI: 90.3%, 97.2%
source quote (p.10)
“specificity was 94.5% (95% CI: 90.3%, 97.2%).”
npvas written: “NPV”99.2CI 95% CI: 98.7%- 99.5%
source quote (p.11)
“NPV was 99.2% (95% CI: 98.7%- 99.5%)”
ppvas written: “PPV”52.9CI 95% CI: 38.6%- 66.6%
source quote (p.11)
“PPV was 52.9% (95% CI: 38.6%- 66.6%).”
ppvas written: “PLR”16.1CI 95% CI: 9.1-28.7
source quote (p.11)
“PLR was 16.1 (95% CI: 9.1-28.7”
npvas written: “NLR”0.1CI 95% CI: 0.1-0.2
source quote (p.11)
“and NLR was 0.1 (95% CI: 0.1-0.2).”
time_to_resultas written: “time-to-notification”29.3CI 95% CI: 26.8-31.9
source quote (p.11)
“BriefCase-Triage mean time-to-notification for the subject Central PE triage was 29.3 seconds (95% CI: 26.8-31.9).”

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
9
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 3 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/K232751