BriefCase

K222329

Aidoc Medical, Ltd. · cleared 2022-09-28 · 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, deep-learning algorithms
source quote (p.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with DICOM 3.0 compliant scanners, PACS, and radiology workstations.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=499 cases · 5 site(s)

endpoints: sensitivity; specificity; time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (7 observations)

sensitivity93.23CI 95% CI: 88.70% - 96.35%
source quote (p.7)
“Sensitivity was 93.23% (95% CI: 88.70% - 96.35%)”
specificity92.83CI 95% CI: 89.35% - 95.45%
source quote (p.7)
“specificity was 92.83% (95% CI: 89.35% - 95.45%).”
npvas written: “NPV”99.8CI 95% CI: 99.7%- 99.9%
source quote (p.8)
“NPV was 99.8% (95% CI: 99.7%- 99.9%)”
ppvas written: “PPV”25CI 95% CI: 18.2%- 19.5%
source quote (p.8)
“PPV was 25.0% (95% CI: 18.2%- 19.5%).”
ppvas written: “PLR”13.01CI 95% CI: 8.682 - 19.494
source quote (p.8)
“PLR was 13.010 (95% CI: 8.682 - 19.494)”
npvas written: “NLR”0.073CI 95% CI: 0.043 - 0.123
source quote (p.8)
“NLR was 0.073 (95% CI: 0.043 - 0.123).”
time_to_resultas written: “mean time-to-notification”38CI 95% CI: 35.5-40.4
source quote (p.7)
“The BriefCase mean time-to-notification for aortic dissection was 38 seconds (95% CI: 35.5-40.4).”

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
19
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 13 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/K222329