BriefCase

K201020

Aidoc Medical, Ltd. · cleared 2020-08-26 · 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 is comprised 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
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
PCCPNo
Cybersecurity addressedNo

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; evaluate Briefcase's potential clinical benefit of worklist prioritization for true positive iPE cases by comparing the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for iPE

Reported performance (6 observations)

sensitivity0.905CI 95% CI: 81.4%, 96.2%
source quote (p.8)
“Specifically, sensitivity was 90.5% (95% CI: 81.4%, 96.2%)”
specificity0.887CI 95% CI: 83.3%, 92.8%
source quote (p.8)
“and specificity was 88.7% (95% CI: 83.3%, 92.8%).”
npvas written: “NPV”0.997CI 95% CI: 99.5%-99.9%
source quote (p.9)
“NPV was 99.7% (95% CI: 99.5%-99.9%)”
ppvas written: “PPV”0.176CI 95% CI: 9.5%-22.1%
source quote (p.9)
“and PPV was 17.6% (95% CI: 9.5%-22.1%).”
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).”

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); 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/K201020