BriefCase

K213721

Aidoc Medical, Ltd. · cleared 2022-03-21 · 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 head CT Angio (CTA) images.”
AlgorithmArtificial intelligence Deep-learning algorithm with database of images
source quote (p.7)
“Artificial intelligence Deep-learning algorithm with database of images.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=268 cases · 5 site(s)

endpoints: evaluate the software's performance in identifying head CTs (with and without contrast) containing Brain Aneurysm; Briefcase's potential clinical benefit of worklist prioritization for true positive BA cases was evaluated by comparing the standard-of-care metric of time-to-exam-open to the software's time-to-notification metric for BA

Reported performance (6 observations)

sensitivity88.5CI 95% CI: 80.4%, 94.1%
source quote (p.8)
“Specifically, sensitivity was 88.5% (95% CI: 80.4%, 94.1%)”
specificity89.5CI 95% CI: 84.0%, 93.7%
source quote (p.8)
“and specificity was 89.5% (95% CI: 84.0%, 93.7%).”
npvas written: “NPV”98.9CI 95% CI: 98.3%-99.6%
source quote (p.9)
“NPV was 98.9% (95% CI: 98.3%-99.6%)”
ppvas written: “PPV”42.4CI 95% CI: 30.0%-51.7%
source quote (p.9)
“PPV was 42.4% (95% CI: 30.0%-51.7%).”
ppvas written: “PLR”8.46CI 95% CI: 5.43%-13.18%
source quote (p.9)
“PLR was 8.46% (95% CI: 5.43%-13.18%)”
npvas written: “NLR”0.13CI 95% CI: 0.07%-0.22%
source quote (p.9)
“NLR was 0.13 (95% CI: 0.07%-0.22%).”

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
24
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 18 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/K213721