BriefCase-Triage: CARE Multi-triage CT Body

Evidence summary

FDA retrospective, blinded, multicenter standalone study at six U.S. sites, with three senior board-certified radiologists as reference standard; each of 11 indications had N=280 and 1,769 unique scans were included across indications. Primary endpoint was finding-level ROC AUC greater than 0.95. FDA reported AUC/Se/Sp by indication: diverticulitis 99.9/98.6/98.5; abscess 99.2/95.0/95.7; appendicitis 99.5/97.9/97.8; intestinal ischemia/pneumatosis 98.8/96.6/96.3; renal stone 98.6/94.0/96.9; small-bowel obstruction 97.4/95.5/96.0; large-bowel obstruction 99.6/97.9/99.3; spleen injury 100/99.3/98.6; liver 99.9/98.6/98.6; kidney injury 99.8/98.6/99.3; pelvic fracture 98.9/96.5/96.4. Mean time-to-notification was 45 seconds (95% CI 43.4-46.5; n=1,523 true-positive cases).

• FDA source
• Exact FDA submission
• Checked 2026-09-08

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

The exact-identifier FDA recall query returned no native recall record for K252970. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.

• Public source
• Exact FDA submission
• Checked 2026-09-08

• Source

• Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
• Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
• Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
• Verify pricing and total cost: No public price or quote for the exact K252970 configuration was established in this review.
• Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
• Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, acr ai central product, fda decision summary, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall