BriefCase-Triage

K251195

Aidoc Medical , Ltd. · cleared 2026-01-27 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced CT images that include the brain, in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence, deep learning algorithm
source quote (p.4)
“BriefCase-Triage uses an artificial intelligence algorithm to analyze images and flag suspect cases in parallel to the ongoing standard of care image interpretation. As is customary in the field of machine learning, deep learning algorithm development consisted of training on manually labeled ("tagged") images.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.13)
“Cybersecurity has been incorporated into the software development lifecycle in alignment with Section 524B of the FD&C Act and FDA cybersecurity guidance. Aidoc utilizes a risk-based approach to cybersecurity, including secure design practices, vulnerability assessments, a Software Bill of Materials (SBOM), and penetration testing. These efforts support the safety, effectiveness, and resilience of the software against cybersecurity threats.”

Validation studies (1)

Retrospective clinical

n=544 cases · 6 site(s)

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

Reported performance (6 observations)

sensitivity87.8CI 95% CI: 83.1%, 91.6%
source quote (p.10)
“For the primary endpoint, sensitivity was 87.8% (95% CI: 83.1%, 91.6%)”
specificity91.6CI 95% CI: 87.9%, 94.5%
source quote (p.10)
“and specificity was 91.6% (95% CI: 87.9%, 94.5%)”
npvas written: “Negative Predictive Value (NPV)”98.9CI 95% CI: 98.4%-99.2%
source quote (p.11)
“NPV was 98.9% (95% CI: 98.4%-99.2%)”
ppvas written: “Positive Predictive Value (PPV)”47.6CI 95% CI: 38.4%-57.1%
source quote (p.11)
“and PPV was 47.6% (95% CI: 38.4%-57.1%).”
time_to_resultas written: “BriefCase-Triage mean time-to-notification”44.8CI 95% CI: 41.4-48.2
source quote (p.10)
“The BriefCase-Triage mean time-to-notification for the subject BA triage was 44.8 seconds (95% CI: 41.4-48.2).”
time_to_resultas written: “Predicate BA mean time-to-notification”252CI 95% CI: 234-270
source quote (p.10)
“The time-to-notification for the predicate BA was 252 seconds (95% CI: 234-270).”

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
1
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

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/K251195