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, 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. 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
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=498 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 (6 observations)

sensitivity91.7CI 95% CI: 87.5%, 94.9%
source quote (p.8)
“Sensitivity was 91.7% (95% CI: 87.5%, 94.9%)”
specificity91.4CI 95% CI: 87.3%, 94.6%
source quote (p.8)
“Specificity was 91.4% (95% CI: 87.3%, 94.6%).”
npvas written: “Negative Predictive Value (NPV)”99.8CI 95% CI: 99.6%- 99.8%
source quote (p.9)
“NPV was 99.8% (95% CI: 99.6%- 99.8%)”
ppvas written: “Positive Predictive Value (PPV)”22.2CI 95% CI: 16.1%-29.9%
source quote (p.9)
“PPV was 22.2% (95% CI: 16.1%-29.9%).”
time_to_resultas written: “Briefcase-Triage time-to-notification (seconds)”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: “Predicate K213886 time-to-notification (seconds)”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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250248