BriefCase

K222329

Aidoc Medical, Ltd. · cleared 2022-09-28 · 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 CT exams with contrast (CTA and CT with contrast) that include the chest in adults or transitional adolescents aged 18 and older.”
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
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

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 (12 observations)

sensitivity93.23CI 88.70% - 96.35%
source quote (p.7)
“Sensitivity was 93.23% (95% CI: 88.70% - 96.35%)”
specificity92.83CI 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: “BriefCase 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).”
time_to_resultas written: “CINA CHEST time-to-notification”36.5CI 95% CI: 35.4-37.5
source quote (p.7)
“The time-to-notification for the CINA CHEST for AD triage was 36.5 seconds (95% CI: 35.4-37.5).”
sensitivityas written: “AOP1 Sensitivity”96.88CI 95% CI: 93.32% - 98.84%
source quote (p.9)
“AOP1: Sensitivity was 96.88% (95% CI: 93.32% - 98.84%)”
specificityas written: “AOP1 Specificity”85.02CI 95% CI: 80.52%- 88.82%
source quote (p.9)
“AOP1: Sensitivity was 96.88% (95% CI: 93.32% - 98.84%) and specificity was 85.02% (95% CI: 80.52%- 88.82%).”
sensitivityas written: “AOP2 Sensitivity”86.46CI 95% CI: 80.79% - 90.96%
source quote (p.9)
“AOP2: Sensitivity was 86.46% (95% CI: 80.79% - 90.96%)”
specificityas written: “AOP2 Specificity”95.11CI 95% CI: 92.07% - 97.24%
source quote (p.9)
“AOP2: Sensitivity was 86.46% (95% CI: 80.79% - 90.96%) and specificity was 95.11% (95% CI: 92.07% - 97.24%).”

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). 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/K222329