BriefCase

K190072

Aidoc Medical, Ltd. · cleared 2019-04-15 · 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.”
Algorithmdeep learning AI algorithms
source quote (p.8)
“Both devices are software packages with similar technological characteristics and principles of operation, 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 (2)

Retrospective clinical

n=2,803 cases · 1 site(s)

endpoints: Specificity; sensitivity

Retrospective clinical

n=184 cases · 3 site(s)

endpoints: software's performance in identifying CTPAS containing pulmonary embolism; worklist prioritization for true positive PE cases

Reported performance (4 observations)

sensitivity0.906CI 95% CI: 82.2%-95.9%
source quote (p.7)
“Specifically, sensitivity was observed to be 90.6% (95% CI: 82.2%-95.9%)”
specificity0.899CI 95% CI: 82.2%-95.1%
source quote (p.7)
“and specificity was observed to be 89.9% (95% CI: 82.2%-95.1%).”
time_to_resultas written: “BriefCase time-to-notification for PE”3.9CI 95% CI: 3.7-4.1
source quote (p.7)
“The BriefCase time-to-notification for PE was 3.9 minutes (95% CI: 3.7-4.1).”
time_to_resultas written: “Standard of care time-to-exam-open”64.1CI 95% CI: 36.6-91.5
source quote (p.8)
“The standard of care time-to-exam-open was much longer (64.1 minutes: 95% CI 36.6-91.5).”

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
32
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 26 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/K190072