qER-Quant

Evidence summary

Standalone testing used expert-manually labeled head CTs and reported target-specific absolute errors and Dice scores: intracranial hyperdensity, 183 scans, mean absolute error 6.56 (7.33) mL and Dice 0.75 (95% CI 0.72-0.78); midline shift, 188 scans, mean absolute error 1.37 (1.23) mm with no Dice reported; left lateral ventricle, 210 scans, mean absolute error 2.09 (1.88) mL and Dice 0.79 (95% CI 0.78-0.81); right lateral ventricle, 210 scans, mean absolute error 2.18 (1.72) mL and Dice 0.75 (95% CI 0.73-0.77). Absolute error and Dice are measurement and segmentation endpoints, not sensitivity or specificity.

• FDA source
• Exact FDA submission
• Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

• 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 K211222. 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 2026-09-09

• Source

• Verify intended users: Identify the intended clinical user and the human action expected after the output.
• 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 K211222 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 packet assessed on 2026-09-19. Directory-backed facts were reconciled only where purpose, modality, and anatomy were each directly established. Candidate literature and postmarket candidates remain in their existing review state. Automated exact-name discovery found 1 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, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, pubmed, clinical trials, openfda device recall