BriefCase-Triage

K242837

Aidoc Medical, Ltd. · cleared 2024-10-18 · 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.”
Algorithmartificial intelligence algorithm, deep-learning algorithms
source quote (p.6)
“BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. 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)No
source quote (p.5)
“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 manually labeled ("tagged") images. Test pivotal study data was sequestered from algorithm development activities, and use of the data is managed by appropriate Quality Management System procedures.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=487 cases · 6 site(s)

endpoints: Primary endpoints were sensitivity and specificity with an 80% performance goal.; Secondary endpoints were BriefCase-Triage time-to-notification compared to the predicate device.; Positive Predictive Value (PPV), Negative Predictive Value (NPV), Positive Likelihood Ratio (PLR), and Negative Likelihood Ratio (NLR) were also assessed.

Reported performance (7 observations)

sensitivity92.1CI 95% CI: 87.5%, 95.4%
source quote (p.9)
“Sensitivity was 92.1% (95% CI: 87.5%, 95.4%)”
specificity92.6CI 95% CI: 89.0%, 95.4%
source quote (p.9)
“Specificity was 92.6% (95% CI: 89.0%, 95.4%).”
npvas written: “NPV”99.1CI 95% CI: 98.5%- 99.4%
source quote (p.10)
“NPV was 99.1% (95% CI: 98.5%- 99.4%)”
ppvas written: “PPV”58.1CI 95% CI: 47.9%-67.7%
source quote (p.10)
“PPV was 58.1% (95% CI: 47.9%-67.7%)”
ppvas written: “PLR”12.4965CI 95% CI: 8.263 - 18.898)
source quote (p.10)
“PLR was 12.4965 (95% CI: 8.263 - 18.898)”
npvas written: “NLR”0.0855CI 95% CI: 0.053 - 0.137)
source quote (p.10)
“NLR was 0.0855 (95% CI: 0.053 - 0.137).”
time_to_resultas written: “Time-to-notification”15.1CI 95% CI: 14.1-16.2
source quote (p.10)
“The BriefCase-Triage mean time-to-notification for the subject CSF triage was 15.1 seconds (95% CI: 14.1-16.2).”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
7
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 1 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/K242837