FDA-cleared profile
Medtronic Navigation, Inc
Authorized purpose: O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact reduction, and lower-dose Spine Smart Dose acquisition for labeled patients.
Product overview
Authorized purpose: O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact reduction, and lower-dose Spine Smart Dose acquisition for labeled patients.
Overview status: Source-reviewed overview
Clinical role: O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact reduction, and lower-dose Spine Smart Dose acquisition for labeled patients.
Evidence from the reviewed source record: 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.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact FDA usability section identifies these clinically relevant users; it does not establish the dossier's added qualified operating-room-staff wording.
The exact FDA product description states the mobile x-ray system's 3D and 2D imaging; the current projection-data and mode list is not stated as an input description in the packet.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
The exact FDA indication supplies the patient-size boundary and image-guided-surgery compatibility statement without the dossier's added performance-dependence interpretation.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
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.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K240465 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Image-guided surgery and navigation integration with DICOM or configured image exchange; validate registration accuracy, orientation, geometry, identifiers, and failure recovery.
exact submission · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Patient size and age thresholds apply. It is primarily for bony anatomy and metal objects; dose, contrast, field length, artifact reduction, and navigation performance depend on acquisition mode and anatomy.
exact submission · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-03Vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: Patient size and age thresholds apply. It is primarily for bony anatomy and metal objects; dose, contrast, field length, artifact reduction, and navigation performance depend on acquisition mode and anatomy.
exact submission · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.
Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.
100 pairs
70 %
25 %
K240465
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
PMID 34111631
Independent technical comparison; protocol and phantom results are not patient outcomes.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
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.
No separate named-product payment identified in reviewed public material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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.
Open, Classified
2025-07-09Exact O-arm O2 match. Confirm affected serial number, inspection, and correction status before relying on the system.
Open, Classified
2026-06-15Exact O-arm O2 model match. Confirm detector firmware and correction status and include artifact recognition in local image-quality controls.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 3 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 3 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 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 were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, fda decision summary, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, modality, anatomy, output, intendedUsers, input, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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