FDA-cleared profile

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Siemens Shenzhen Magnetic Resonance, Ltd.

Authorized purpose: MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and information about internal structure and function for trained physician interpretation.

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

Overview status: Source-reviewed overview

What does this software do? Authorized purpose: MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and information about internal structure and function for trained physician interpretation.
Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Head, body, and extremities Input: Patient MRI signal data acquired with supported coils, pulse sequences, field strengths, contrast, and release-specific protocols.
Who uses it? Intended users: Qualified MRI technologists and physicians trained in magnetic resonance imaging.
What does the software produce? Output: Cross-sectional MR images, spectra, derived parameters, and reconstructed series for professional review.
What is its most important limitation? Key limitation: Field strength, coil, sequence, anatomy, population, implant, intervention, and optional-feature limits vary by model and release.

Clinical takeaway

Clinical role: MAGNETOM Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and information about internal structure and function for trained physician interpretation.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA 510(k) decision material establishes the submission identity, labeled use, inputs, population, and configuration boundary summarized here. No product-wide clinical-performance or outcome claim is promoted without an exact endpoint and version linkage.

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 Flow.Ace and Flow.Plus are diagnostic MR systems that produce transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and spectra, and information about internal structure and function for trained physician interpretation.

Intended users: Qualified MRI technologists and physicians trained in magnetic resonance imaging.

Care setting and population: Hospital and outpatient MRI departments operating the cleared field strength, coils, protocols, and accessories.

Workflow role: MRI acquisition, reconstruction, display, review, and release-specific workflow support.

Required input: Patient MRI signal data acquired with supported coils, pulse sequences, field strengths, contrast, and release-specific protocols.

Output and human action: Cross-sectional MR images, spectra, derived parameters, and reconstructed series for professional review.

Limitations: Field strength, coil, sequence, anatomy, population, implant, intervention, and optional-feature limits vary by model and release.

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: K250436

Modality: MRI

Anatomy: Head, body, and extremities

Clearance type: 510(k)

Decision date: 2025-06-16

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

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

Integration: Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.

Deployment and data flow: Not established in reviewed sources

Security and privacy: Not established in reviewed sources

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.

Monitoring and change control: Not established in reviewed sources

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K250436 before acceptance.

exact submission · checked 2026-09-04

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

Source

Interoperability acceptance

Exact public integration details remain incomplete; establish and test the supported input, output, identity, routing, archive, report, and downtime contract locally.

exact submission · checked 2026-09-04

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

Source

Clinical acceptance

Use a signed local test set for the exact labeled 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.

exact submission · checked 2026-09-04

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 2026-09-04

No exact-product price was found in reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

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.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. No exact native-submission recall record was found in the checked snapshot; this does not exclude other product-family or later signals.

Source Source

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: The exact FDA 510(k) decision material establishes the submission identity, labeled use, inputs, population, and configuration boundary summarized here. No product-wide clinical-performance or outcome claim is promoted without an exact endpoint and version linkage.

Reported sensitivity: Not established in reviewed sources

Reported specificity: Not established in reviewed sources

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K250436 FDA evidence package for MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

DesignFDA 510(k) decision evidence package reviewed for exact submission identity and labeled scope
PopulationLabeled population and configuration described in the K250436 FDA decision material
Scopeexact submission
Tested versionMAGNETOM Flow.Ace and Flow.Plus configuration described in K250436
IndependenceSponsor or vendor study

K250436

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.

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

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.

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: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K250436 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Buyer worksheet

Open questions to take to the vendor

Verify deployment and data flow: The exact FDA decision material does not establish the complete deployment topology, hosting responsibility, availability, upgrade path, or service contract.
Verify security and privacy controls: 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.
Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
Verify local validation and lifecycle monitoring: The exact FDA decision and checked recall snapshot do not establish a complete local postmarket monitoring protocol. Track version, population, anatomy, protocol, input quality, edits, failures, repeats, downstream effects, downtime, incidents, recalls, and updates locally.

Open evaluation checklist

Research record

What has been checked

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

Exact FDA record reviewedStatus

2026-09-20Last searched

27Fields reviewed

12Source classes checked

0Screened PubMed leads

0Screened trial leads

0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 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 summary, 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

How this profile was documented

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

View source ledger and history

Source ledger

FDA 510(k) decision material K250436: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

U.S. Food and Drug Administration - Published 2025-06-16 - Accessed 2026-09-04

Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary
Artificial Intelligence-Enabled Medical Devices

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

Scope: regulatoryIdentity, modalityContext
PubMed biomedical literature index

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

Scope: evidenceDiscovery
ClinicalTrials.gov study registry

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

Scope: evidenceDiscovery, studyStatus
Medicare Coverage Database

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

Scope: coverage, codingContext
openFDA Device Recall API

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

Scope: recallDiscovery, nativeSubmissionMatching

Research history

2025-06-16

K250436 FDA decision

Regulatory record

510(k)
2026-09-20

Source-review record updated

Research record

fda record reviewed
2026-09-20

Reader overview source-reviewed

Editorial review

Source-reviewed editorial overlay

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