FDA-cleared profile
Siemens Healthineers AG
Authorized purpose: BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment planning and interventions.
Product overview
Authorized purpose: BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment planning and interventions.
Overview status: Source-reviewed overview
Clinical role: BIOGRAPH One with syngo MR XB10 combines metabolic or physiologic PET information with MR anatomy, MR-based attenuation correction, fused alignment, and support for treatment planning and interventions.
Evidence from the reviewed source record: K253023 reports nonclinical PET, MR, attenuation-correction, fusion, image-quality, system, software, and sample-image validation.
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.
This replaces the current MRI-technologist wording with the packet's direct user statement.
The packet directly identifies contrast agents and PET radiopharmaceuticals; it does not state the current MRI-signal-only input value.
The direct FDA indication describes MRI and PET images, attenuation-correction maps, and fused MR/PET images rather than the current generic reconstruction and workflow outputs.
This uses only the packet's stated conditions and uses; the current field-strength, coil, population, and optional-feature limits are not stated in the exact text.
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.
The FDA indications identify MRI and PET; SPECT and the broader nuclear-medicine label in the current value are not stated in this packet. Controlled directory display reconciled from exact FDA wording: Magnetic Resonance Imaging (MRI) and PET. -> PET/SPECT/Nuclear Medicine.
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 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.
Map the installed model, build, options, population, anatomy, inputs, and outputs to K253023 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.
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. Field strength, coil, sequence, anatomy, population, 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 2026-09-03Vendor 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 these product-specific limits: Field strength, coil, sequence, anatomy, population, and optional-feature limits vary by model and release; map the installed configuration to the exact clearance and labeling.
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 endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.
Specificity is not the primary endpoint for this acquisition, 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.
K253023
Manufacturer evidence submitted for clearance or approval; local clinical, technical, 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, 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 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.
The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. 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 1 PubMed and 0 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 material, vendor product page, 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, anatomy, modality, intendedUsers, input, output, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: integration, deployment, monitoring, productFamilyContext
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
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