FDA-cleared profile
MRIguidance B.V
Authorized purpose: BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and does not replace CT.
Product overview
Authorized purpose: BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and does not replace CT.
Overview status: Source-reviewed overview
Clinical role: BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors and does not replace CT.
Evidence from the reviewed source record: K202404 FDA decision material describes the cleared MRI image-enhancement software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
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.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K202404 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The exact public deployment topology remains incomplete; establish hosting responsibility, data flow, availability, upgrade, service, and downtime boundaries locally.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.
exact submission · checked 2026-09-04Test 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. The enhanced image is not intended for primary or metastatic tumor diagnosis or monitoring and is not a replacement for CT; pelvic anatomy and dedicated MRI protocol limits apply.
exact submission · checked 2026-09-04Define 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 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K202404 by exact hardware, software, model, and algorithm 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 these product-specific limits: The enhanced image is not intended for primary or metastatic tumor diagnosis or monitoring and is not a replacement for CT; pelvic anatomy and dedicated MRI protocol limits apply.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. MRI image-enhancement software limits remain submission-specific.
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 promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K202404
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
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, 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 StatesThis is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 18 PubMed and 3 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 18 PubMed and 3 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Regulatory record
510(k)
Research record
human reviewed
Editorial review
Source-reviewed editorial overlay
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