Radiology AI Directory

FDA-cleared profile

MAGNETOM Avanto fit; MAGNETOM Skyra fit

Siemens Medical Solutions USA, Inc.

Authorized purpose: MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an open reconstruction framework.

MRI workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an open reconstruction framework.

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 takeaway

Clinical role: MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an open reconstruction framework.

Evidence takeaway

FDA record boundary: K232494 reports bench, software, and sample-image testing and cites a publication for gradient-echo MR elastography; no clinical study was performed for the release.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
MAGNETOM Avanto fit and Skyra fit with syngo MR XA61A provide broad diagnostic and interventional MRI and add coils, phase-contrast gradient echo, physiological logging, and an open reconstruction framework.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet uses this healthcare-professional wording and does not establish the dossier's MRI-technologist and physician role list.

Care setting and population
Hospital and outpatient MRI departments operating the cleared field strength, coils, protocols, and accessories.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
MRI acquisition, reconstruction, review, and release-specific workflow support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Value withdrawn pending re-verification
  • Corrected record
  • Exact FDA submission
  • Checked 2026-09-19

Previous value withdrawn: The exact FDA decision-summary packet reviewed on 2026-09-19 does not establish this claim.

Output and human action
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This replaces reconstructed-image and generic workflow-result wording with the packet's direct outputs.

Limitations
These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet states the trained-physician interpretation boundary; it does not state the dossier's model, release, and option-mapping limitation.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K232494
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-14
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Scanner-console and DICOM workflow to PACS or downstream applications; validate worklist, identifiers, series labels, geometry, measurements, routing, and archive completeness.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Installed MRI hardware and release-specific scanner software with licensed coils, sequences, and options.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

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.

Training and support
Only qualified mri technologists and physicians trained in magnetic resonance imaging. should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K232494 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Scanner-console and DICOM workflow to PACS or downstream applications; validate worklist, identifiers, series labels, geometry, measurements, routing, and archive completeness.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

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 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

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 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

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 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

Evidence

Performance 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.

Evidence summary
K232494 reports bench, software, and sample-image testing and cites a publication for gradient-echo MR elastography; no clinical study was performed for the release.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary endpoint for this acquisition, reconstruction, segmentation, guidance, or quantitative function. Use the task-specific evidence below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

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.

K232494 FDA performance package for MAGNETOM Avanto fit; MAGNETOM Skyra fit

  • DesignManufacturer nonclinical system, software, and sample-image verification
  • PopulationBroad head, body, extremity, and interventional MRI applications
  • Scopeexact submission
  • Tested versionMAGNETOM Avanto fit and Skyra fit with syngo MR XA61A
  • IndependenceSponsor or vendor study

K232494

Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

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.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
1 reviewed FDA recall record in the 2026-09-02 openFDA snapshot natively identify K232494. Confirm affected model, version, unit, correction, and current manufacturer instructions. FDA recall Z-2662-2025 affects specified MAGNETOM Skyra Fit BioMatrix systems. Ice blockage in magnet venting could prevent helium from escaping during a quench and cause pressure buildup or helium leakage. FDA lists the recall as open and classified.
  • FDA source
  • Exact product version
  • Checked 2026-09-04

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.

recall: Z-2662-2025

Open, Classified

2025-09-30

Exact Skyra Fit product-family and native submission match; confirm model and affected-unit status because K232494 also includes Avanto fit.

Source

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
10Source classes checked
0Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

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. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 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, reimbursement policy, fda device recall, fda decision summary packet, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K232494: MAGNETOM Avanto fit; MAGNETOM Skyra fit

    U.S. Food and Drug Administration - Published 2023-11-14 - Accessed 2026-09-19

    Scope: modality, anatomy, evidenceSummary, purpose, intendedUsers, output, limitations, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-2662-2025: MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

    U.S. Food and Drug Administration - Published 2025-09-30 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Siemens MR interoperability information

    Siemens Healthineers - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

Research history

  1. K232494 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. FDA-bounded reader overview

    Editorial review

    Exact FDA fact-bound editorial overlay; not a source or clinician review

Alternatives

Related tools to compare

FDA-cleared K260746

S-scan Open (100001800)

Esaote, S.p.A.

S-scan Open is an Esaote MR system for diagnostic image acquisition, reconstruction, display, and professional interpretation within the labeled scanner, coil, sequence, and...

Modality
MRI
Anatomy
Multi-region
Decision
2026-03-27
MRI workflow
FDA-cleared K252379

AIR Recon DL

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...

Modality
MRI
Anatomy
Multi-region
Decision
2025-12-23
MRI workflow