Ceevra Reveal 3+

Evidence summary

FDA validation covered 133 CT and MR imaging studies and reported structure-specific segmentation results, including prostate MR Dice similarity coefficient 0.90, kidney CT Dice similarity coefficient 0.92 and neurovascular-bundle MR 95th-percentile Hausdorff distance 6.6 mm.

• FDA source
• Exact FDA submission
• Checked 2026-09-06

• Source

Postmarket safety review

Not established in reviewed sources

• Reviewed sources checked
• Exact FDA submission
• Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify security and privacy controls: The family page's HIPAA wording is not treated as a current exact-release security attestation.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: A family subscription structure is public, but no numeric price or exact K243933 contract amount was published.
• Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
• Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor manual, peer reviewed publication, clinical trial registry, recall database, pubmed, clinical trials, openfda device recall