BriefCase

K222277

Aidoc Medical, Ltd. · cleared 2022-08-26 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“BriefCase is a radiological computer-assisted triage and notification software device. The software system is based on an algorithm programmed component and consists of a standard off-the-shelf operating system, the Microsoft Windows server 2012 64bit, and additional applications, which include PostgreSQL, DICOM module and the BriefCase Image Processing Application.”
Algorithmartificial intelligence algorithm, deep-learning algorithms
source quote (p.3)
“BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation.”
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 time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (11 observations)

sensitivity0.9486CI 90.99%, 97.41%
source quote (p.8)
“Sensitivity was 94.86% (95% CI: 90.99%, 97.41%)”
specificity0.9404CI 90.62%, 96.49%
source quote (p.8)
“specificity was 94.04% (95% CI: 90.62%, 96.49%).”
npvas written: “NPV”0.99CI 98.3%- 99.5%
source quote (p.9)
“NPV was 99.0% (95% CI: 98.3%- 99.5%)”
ppvas written: “PPV”0.737CI 63.9%- 81.7%
source quote (p.9)
“PPV was 73.7% (95% CI: 63.9%- 81.7%).”
ppvas written: “PLR”15.903CI 10.019 - 25.242
source quote (p.9)
“PLR was 15.903 (95% CI: 10.019 - 25.242)”
npvas written: “NLR”0.055CI 0.031- 0.097
source quote (p.9)
“NLR was 0.055 (95% CI: 0.031- 0.097).”
time_to_resultas written: “BriefCase mean time-to-notification”78CI 73.6-82.3
source quote (p.9)
“The BriefCase mean time-to-notification for BriefCase for PE triage was 78.0 seconds (95% CI: 73.6-82.3).”
sensitivityas written: “AOP1 Sensitivity”0.986CI 95.96%-99.71%
source quote (p.10)
“AOP1: Sensitivity was 98.60% (95% CI: 95.96%-99.71%)”
specificityas written: “AOP1 Specificity”0.8526CI 80.61%-89.17%
source quote (p.10)
“specificity was 85.26% (95% CI: 80.61%-89.17%).”
sensitivityas written: “AOP2 Sensitivity”0.8645CI 81.12%-90.73%
source quote (p.10)
“AOP2: Sensitivity was 86.45% (95% CI: 81.12%-90.73%)”
specificityas written: “AOP2 Specificity”0.9825CI 95.95%-99.43%
source quote (p.10)
“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
20
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 14 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/K222277