BriefCase-Triage

K250248

Aidoc Medical, Ltd. · cleared 2025-02-14 · 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 algorithm, deep learning algorithm
source quote (p.3)
“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. 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. 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. In that process, critical findings were tagged in all CTs in the training data set.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=498 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 (8 observations)

sensitivity0.917CI 95% CI: 87.5%, 94.9%
source quote (p.8)
“Sensitivity was 91.7% (95% CI: 87.5%, 94.9%)”
specificity0.914CI 95% CI: 87.3%, 94.6%
source quote (p.8)
“Specificity was 91.4% (95% CI: 87.3%, 94.6%).”
npvas written: “NPV”0.998CI 95% CI: 99.6%- 99.8%
source quote (p.9)
“NPV was 99.8% (95% CI: 99.6%- 99.8%)”
ppvas written: “PPV”0.222CI 95% CI: 16.1%-29.9%
source quote (p.9)
“PPV was 22.2% (95% CI: 16.1%-29.9%).”
ppvas written: “PLR”10.7CI 95% CI: 7.2-16.0
source quote (p.9)
“PLR was 10.7 (95% CI: 7.2-16.0)”
npvas written: “NLR”0.09CI 95% CI: 0.06-0.14
source quote (p.9)
“NLR was 0.09 (95% CI: 0.06-0.14).”
time_to_resultas written: “Time-to-notification (subject device)”40.2CI 95% CI: 36.9-43.5
source quote (p.8)
“The Briefcase-Triage mean time-to-notification for the subject iPE triage was 40.2 seconds (95% CI: 36.9-43.5).”
time_to_resultas written: “Time-to-notification (predicate device)”282CI 95% CI: 264-306
source quote (p.8)
“The time-to-notification for the predicate iPE was 282 seconds (95% CI: 264-306).”

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
5
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

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/K250248