O-arm O2 Imaging System

Evidence summary

K240465 reports blinded review of 100 clinical image pairs, with Spine Smart Dose judged clinically equivalent at roughly one-quarter of corresponding standard-mode dose. Independent comparative research found mode-dependent dose and low-contrast tradeoffs, supporting local protocol testing.

Public source Exact FDA submission Checked 2026-09-03

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Postmarket safety review

2 reviewed FDA recall records in the 2026-09-02 openFDA snapshot natively identify K240465. Read the model- and version-scoped events and confirm affected-unit and correction status with the manufacturer. FDA recall Z-2101-2025 affects O-arm O2 systems because a gantry-support mechanical component might have been damaged during manufacture. FDA lists the recall as open and classified. FDA recall Z-2451-2026 affects O-arm O2 detector-panel firmware because an anomaly could cause image artifacts. FDA lists the recall as open and classified.

FDA source Exact FDA submission Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

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• Verify security and privacy controls: Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
• Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 3 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. 2 FDA recall candidates were manually reviewed: 2 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 2 postmarket candidate records; 2 have been reviewed (2 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, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• K240465 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
• FDA recall Z-2101-2025: O-arm O2 Imaging System. Mobile X-Ray System. U.S. Food and Drug Administration · 2026-09-04
• FDA recall Z-2451-2026: Medtronic O-arm O2 Imaging System. Model Number: BI70002000. U.S. Food and Drug Administration · 2026-09-04
• 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
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• O-arm surgical imaging system Medtronic · 2026-09-03
• Radiation exposure and image quality comparison of O-arm O2 and another intraoperative imaging system European Spine Journal · 2026-09-03