FDA-cleared profile
Siemens Medical Solutions USA, Inc.
Authorized purpose: MAGNETOM Free.Max and Free.Star are 0.55T MRI systems for broad head, body, extremity, and release-specific diagnostic imaging workflows.
Product overview
Authorized purpose: MAGNETOM Free.Max and Free.Star are 0.55T MRI systems for broad head, body, extremity, and release-specific diagnostic imaging workflows.
Overview status: FDA-bounded overview This overview only restates exact FDA-supported facts. It does not use candidate literature or vendor claims, and it is not a full source or clinician review.
Clinical role: MAGNETOM Free.Max and Free.Star are 0.55T MRI systems for broad head, body, extremity, and release-specific diagnostic imaging workflows.
FDA record boundary: K231617 reports MR system, software, reconstruction, image-quality, and safety validation for the 0.55T configurations, including large image-set testing. The public package does not establish a universal clinical outcome or diagnostic-performance value.
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 packet identifies a trained physician as interpreter and does not establish the dossier's MRI-technologist role wording.
Previous value withdrawn: The exact FDA decision-summary packet reviewed on 2026-09-19 does not establish this claim.
The packet states cross-sectional images and derived physical parameters, but does not state spectra or reconstructed-series output for this submission.
The packet states the trained-physician interpretation boundary; it does not state the dossier's model and release variability limitation.
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.
Current vendor materials are product-family evidence for K231617; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Current vendor materials are product-family evidence for K231617; confirm the exact cleared version, enabled options, deployment, and local compatibility.
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.
Current vendor materials are product-family evidence for K231617; confirm the exact cleared version, enabled options, deployment, and local compatibility.
Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled AI functions to K231617 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
Scanner-console and DICOM workflow to PACS or downstream applications; validate worklist, identifiers, series labels, geometry, measurements, routing, and archive completeness.
product family · checked 2026-09-03Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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. Field strength, coil, sequence, anatomy, population, implant, intervention, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.
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 2026-09-03No exact-product price was found in the reviewed public material; vendor productivity claims are scenario inputs, not guaranteed local savings.
Monitor 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: Field strength, coil, sequence, anatomy, population, implant, intervention, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.
product family · checked 2026-09-03Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. Vendor statements are current product-family context; confirm the exact cleared release and installed options.
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 endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this system, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K231617
Manufacturer evidence submitted for FDA clearance or approval; local clinical, technical, and workflow acceptance remains necessary.
1 unlinked candidate evidence record is retained for source review and excluded from this evidence display.
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 StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.
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.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA packet assessed on 2026-09-19. Directory-backed facts were reconciled only where purpose, modality, and anatomy were each directly established. Candidate literature and postmarket candidates remain in their existing review state. Automated exact-name discovery found 0 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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, fda decision material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, fda decision summary packet, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: modality, anatomy, purpose, intendedUsers, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, deployment, monitoring, productFamilyContext
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Exact FDA fact-bound editorial overlay; not a source or clinician review
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