BriefCase-Triage

K241727

Aidoc Medical, Ltd. · cleared 2024-07-12 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Briefcase-Triage is a radiological computer-assisted triage and notification software device.”
Algorithmartificial intelligence, deep-learning algorithm
source quote (p.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporated in software packages for use with DICOM compliant CT 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 · 6 site(s)

endpoints: sensitivity; specificity; Briefcase-Triage time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (15 observations)

sensitivity94.39CI 95% CI: 90.41%, 97.07%
source quote (p.8)
“Sensitivity was 94.39% (95% CI: 90.41%, 97.07%)”
specificity94.39CI 95% CI: 91.04%, 96.67%
source quote (p.8)
“Specificity was 94.39% (95% CI: 91.04%, 96.67%).”
time_to_resultas written: “Mean time-to-notification”26.42CI 95% CI: 25.3-27.54
source quote (p.9)
“The Briefcase-Triage mean time-to-notification for the subject PE triage was 26.42 seconds (95% CI: 25.3-27.54).”
npvas written: “NPV”98.96CI 95% CI: 98.21%- 99.4%
source quote (p.9)
“NPV was 98.96% (95% CI: 98.21%- 99.4%)”
ppvas written: “PPV”74.79CI 95% CI: 64.80%- 82.7%
source quote (p.9)
“PPV was 74.79% (95% CI: 64.80%- 82.7%).”
ppvas written: “PLR”16.81CI 95% CI: 10.43- 27.09
source quote (p.9)
“PLR was 16.81 (95% CI: 10.43- 27.09)”
npvas written: “NLR”0.059CI 95% CI: 0.034- 0.103
source quote (p.9)
“NLR was 0.059 (95% CI: 0.034- 0.103).”
sensitivityas written: “Sensitivity (AOP1)”99.53CI 95% CI: 97.42%- 99.99%
source quote (p.11)
“Sensitivity was 99.53% (95% CI: 97.42%- 99.99%)”
specificityas written: “Specificity (AOP1)”86.67CI 95% CI: 82.16%-90.39%
source quote (p.11)
“Specificity was 86.67% (95% CI: 82.16%-90.39%).”
sensitivityas written: “Sensitivity (AOP2)”97.66CI 95% CI: 94.63%-99.24%
source quote (p.11)
“Sensitivity was 97.66% (95% CI: 94.63%-99.24%)”
specificityas written: “Specificity (AOP2)”91.93CI 95% CI: 88.14%-94.82%
source quote (p.11)
“Specificity was 91.93% (95% CI: 88.14%-94.82%.”
sensitivityas written: “Sensitivity (AOP3)”91.59CI 95% CI: 87.03%- 94.94%
source quote (p.11)
“Sensitivity was 91.59% (95% CI: 87.03%- 94.94%)”
specificityas written: “Specificity (AOP3)”96.49CI 95% CI: 93.64%-98.3%
source quote (p.11)
“Specificity was 96.49% (95% CI: 93.64%-98.3%).”
sensitivityas written: “Sensitivity (AOP4)”85.98CI 95% CI: 80.6%-90.34%
source quote (p.11)
“Sensitivity was 85.98% (95% CI: 80.6%-90.34%)”
specificityas written: “Specificity (AOP4)”98.25CI 95% CI: 95.95%-99.43%
source quote (p.11)
“Specificity was 98.25% (95% CI: 95% CI: 95.95%-99.43%).”

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
8
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 2 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/K241727