BoneMRI

Evidence summary

K233030 BoneMRI was validated with paired BoneMRI and CT images from 76 pelvic and 117 spine patients. The FDA summary reports bounds for morphology and radiodensity agreement, not exact aggregate point estimates.

FDA source Exact FDA submission Checked 2026-09-07

• Source

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

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 FDA deployment description does not establish formal security controls for a current installed configuration.
• Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
• Verify pricing and total cost: No public exact-submission price or procurement terms were reviewed.
• Verify reimbursement and coding relevance: CMS policy research was not performed by this worker; no coverage conclusion is made.
• 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 PubMed and ClinicalTrials candidate metadata were screened in the exact stored order; this was metadata triage, not full-text paper or registry-record review, and no candidate was promoted. The stored recall query returned no records, so no event was promoted and no absence claim is made. The current discovery snapshot contains 18 PubMed and 2 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, literature index, trial registry, stored candidate metadata, stored recall candidates, pubmed, clinical trials, openfda device recall

• K233030 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• BoneMRI model card (K233030) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• FDA 510(k) decision summary K233030: BoneMRI U.S. Food and Drug Administration · 2026-09-07
• BoneMRI official product and workflow page MRIguidance B.V. · 2026-09-07