BriefCase

K201020

Aidoc Medical, Ltd. · cleared 2020-08-26 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast enhanced chest CT images (but not dedicated CTPA protocol) CT. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive cases of Incidental Pulmonary Embolism (IPE) pathologies.”
Algorithmdeep learning AI algorithms
source quote (p.9)
“Both devices are software packages with similar technological characteristics and principles of operation, both incorporating deep learning AI algorithms that process images, and software to send notifications and unannotated compressed preview images to the radiologists' workstation.”
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=268 cases · 2 site(s)

endpoints: evaluate the software's performance in identifying Contrast-enhanced chest CTs (but not dedicated CTPA protocol), containing Incidental Pulmonary Embolism; Briefcase's potential clinical benefit of worklist prioritization for true positive iPE cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for iPE

Reported performance (7 observations)

sensitivity90.5CI 95% CI: 81.4%, 96.2%
source quote (p.8)
“Specifically, sensitivity was 90.5% (95% CI: 81.4%, 96.2%)”
specificity88.7CI 95% CI: 83.3%, 92.8%
source quote (p.8)
“and specificity was 88.7% (95% CI: 83.3%, 92.8%).”
time_to_resultas written: “BriefCase time-to-notification for iPE”4.7CI 95% CI: 4.4-5.1
source quote (p.8)
“The BriefCase time-to-notification for iPE was 4.7 minutes (95% CI: 4.4-5.1; Median: 5.0, IQR: 2.3).”
time_to_resultas written: “standard of care time-to-exam-open”223.3CI 95% CI: 125.8-320.7
source quote (p.8)
“In contrast, standard of care time-to-exam-open was much longer, 223.3 minutes (95% CI: 125.8-320.7; Median: 70.4, IQR: 217.6).”
time_to_resultas written: “mean difference of time-to-exam-open and time-to-notification”220.9CI 95% CI: 122.0-319.9
source quote (p.8)
“The mean difference of 220.9 minutes (95% CI: 122.0-319.9; Median: 63.2, IQR: 219.8) for these two metrics is statistically significant and assuming the radiologist receives a notification on a true positive iPE case and acts on it immediately, it can on average save more than three hours compared to the time-to-exam-open in a first in first out (FIFO) reading queue.”
npvas written: “NPV”99.7CI 95% CI: 99.5%-99.9%
source quote (p.9)
“NPV was 99.7% (95% CI: 99.5%-99.9%)”
ppvas written: “PPV”17.6CI 95% CI: 9.5%-22.1%
source quote (p.9)
“and PPV was 17.6% (95% CI: 9.5%-22.1%).”

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
28
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 22 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/K201020