BriefCase-Triage: CARE Multi-triage CT Body

K252970

Aidoc Medical , Ltd. · cleared 2026-01-07 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Briefcase-Triage is a radiological computer-assisted triage and notification software device. The software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.”
Algorithmartificial intelligence, deep-learning algorithm, foundation model-based
source quote (p.7)
“Both devices are artificial intelligence, deep-learning algorithms incorporated in software components for use with DICOM format CT images, PACS, and radiology workstations. Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”
Adaptive (vs locked)No
source quote (p.11)
“Multi-triage module, locked artificial intelligence algorithm fine tuned from a foundation model.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.27)
“Cybersecurity has been incorporated into the software development lifecycle in alignment with Section 524B of the FD&C Act and FDA cybersecurity guidance. Aidoc has implemented a risk-based approach to cybersecurity, including secure design practices, vulnerability assessments, a Software Bill of Materials (SBOM), and penetration testing. These efforts demonstrate that the software is substantially equivalent to the predicate with respect to resilience against cybersecurity threats.”

Validation studies (1)

Retrospective clinical

n=280 patients · 6 site(s)

endpoints: area under the curve (AUC) > 0.95; sensitivity; specificity; BriefCase time-to-notification; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (4 observations)

sensitivity0.986CI 95.1%-99.8%
source quote (p.12)
“Se 98.6% 95% CI 95.1%-99.8%”
specificity0.985CI 94.7%-99.8%
source quote (p.12)
“Sp 98.5% 95% CI 94.7%-99.8%”
aurocas written: “auc”0.999CI 99.7-100
source quote (p.12)
“AUC 99.9 95% CI 99.7-100”
time_to_resultas written: “Time-to-notification (seconds)”45CI 43.4-46.5
source quote (p.14)
“The Briefcase-Triage mean time-to-notification for the subject device triage was 45 seconds (95% CI: 43.4-46.5).”

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) 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

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/K252970