FDA-cleared profile
Siemens Healthcare GmbH
The listed MAGNETOM 1.5T and 3T MRI systems produce cross-sectional images, spectroscopic images or spectra, and derived physical parameters of the head, body, and extremities for trained-physician interpretation and can support imaging during MR-compatible interventions.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Added in P2 round17 from the exact FDA decision material; later product-family claims remain separate.
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.
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 K252838 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that this cleared release includes them.
DICOM network integration and model-specific MR console workflows; validate PACS, RIS, worklist, structured results, image scaling, and advanced-object compatibility.
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. Features and performance differ across Sola, Altea, Sola Fit, Viato.Mobile, Vida, Lumina, Vida Fit, Flow.Elite, Flow.Neo, and Flow.Rise. Confirm field strength, coil, sequence, Deep Resolve, mobility, and interventional support for the exact system.
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: Features and performance differ across Sola, Altea, Sola Fit, Viato.Mobile, Vida, Lumina, Vida Fit, Flow.Elite, Flow.Neo, and Flow.Rise. Confirm field strength, coil, sequence, Deep Resolve, mobility, and interventional support for the exact system.
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.
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.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Manufacturer bench, phantom, software, image-quality, safety, usability, and feature validation for the syngo MR XB10 system family · Representative head, body, extremity, spectroscopy, and model-specific MR acquisition workflows
exact submission · Tested version: MAGNETOM systems with syngo MR XB10 cleared in K252838 · Sponsor or vendor studyK252838
Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.
Economics and lifecycle
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.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Twenty PubMed records and ten trial records were screened. The records concern MRI or machine learning generally but do not identify the exact listed MAGNETOM configuration with syngo MR XB10/K252838. No evidence was promoted, and all 30 candidates remain quarantined. The current discovery snapshot contains 20 PubMed and 10 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, vendor product page, reimbursement policy, fda device recall, fda decision material, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
Alternatives
Canon Medical Systems Corporation
Vantage Fortian and Orian 1.5T produce diagnostic MR images of the head and body, including labeled noncontrast angiography, for trained technologists and physician interpretation.
Esaote, S.p.A.
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Ge Medical Systems, LLC
AIR Recon DL adds a deep-learning phase-correction and reconstruction option to supported GE 1.5T, 3T, and 7T MR workflows for all labeled anatomies and ages to reduce noise or...
Siemens Shenzhen Magnetic Resonance, Ltd.
MAGNETOM Free.Max and Free.Star with syngo MR XA80A are 0.55T MRI systems for broad imaging and compatible interventions; this release adds dentomaxillofacial coil and assist...