Radiology AI Directory

FDA-cleared profile

MAGNETOM Terra; MAGNETOM Terra.X

Siemens Medical Solutions USA, Inc.

Authorized purpose: MAGNETOM Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head within labeled limits.

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 Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head within labeled limits.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: MAGNETOM Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head within labeled limits.

Evidence takeaway

Evidence from the reviewed source record: K232322 reports bench, software, coil, hardware, and sample-image testing; no broad clinical-outcome study was required.

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 Terra and Terra.X with syngo MR XA60A provide 7T proton MRI of the head and extremities, sodium head imaging, and phosphorus spectroscopy of the body excluding the head within labeled limits.
  • 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
Trained physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The indications statement names a trained physician and does not establish MRI technologists as an intended-user class.

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
k-space raw-data acquired with supported RF coils and pulse sequences.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet directly identifies k-space raw-data, RF coils, and pulse sequences; it does not state the dossier's generic patient-signal wording.

Output and human action
Transverse, sagittal, coronal and oblique cross-sectional images, Sodium images for the head, and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head. Other physical parameters derived from the images and/or spectra may also be produced.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The replacement uses the exact imaging, spectroscopy, and derived-parameter scope and removes unsupported workflow-result wording.

Limitations
The weight limit is moved from the system intended use to the RF coil intended use, with an adapted SAR calculation and a changed intended population for the 31P/1H TxRx Flex Loop 7T coil.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

This is the packet's direct coil-specific scope and safety boundary; the dossier's broad whole-body proton-MRI statement is not a quoted packet 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
K232322
  • 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
Head/Extremities
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The packet includes the phosphorus whole-body-excluding-head scope in addition to head and extremity imaging; the current Head/Extremities value is incomplete. Controlled directory display reconciled from exact FDA wording: Head or extremities for transverse, sagittal, coronal and oblique cross-sectional images; whole body excluding the head for Phosphorus spectroscopic images and/or spectra. -> Head/Extremities.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-03-22
  • 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: The clearance does not establish broad whole-body proton MRI. Apply the exact nucleus, anatomy, coil, sequence, and accessory restrictions for each examination.
  • 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 K232322 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. The clearance does not establish broad whole-body proton MRI. Apply the exact nucleus, anatomy, coil, sequence, and accessory restrictions for each examination.

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: The clearance does not establish broad whole-body proton MRI. Apply the exact nucleus, anatomy, coil, sequence, and accessory restrictions for each examination.

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
K232322 reports bench, software, coil, hardware, and sample-image testing; no broad clinical-outcome study was required.
  • 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.

K232322 FDA performance package for MAGNETOM Terra; MAGNETOM Terra.X

  • DesignManufacturer nonclinical 7T system, coil, software, and sample-image verification
  • PopulationHead and extremity proton MRI plus labeled sodium and phosphorus applications
  • Scopeexact submission
  • Tested versionMAGNETOM Terra and Terra.X with syngo MR XA60A
  • IndependenceSponsor or vendor study

K232322

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K232322 by exact submission identifier. This does not exclude product-family or later safety information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Exact-identifier review does not prove absence of all product-family safety signals.

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
12Source classes checked
10Screened PubMed leads
2Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 10 PubMed and 2 ClinicalTrials.gov candidate records. 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 10 PubMed and 2 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, vendor product page, reimbursement policy, fda device recall, fda decision summary packet, 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

  1. FDA K232322: MAGNETOM Terra; MAGNETOM Terra.X

    U.S. Food and Drug Administration - Published 2024-03-22 - Accessed 2026-09-19

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

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

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

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Siemens MR interoperability information

    Siemens Healthineers - Accessed 2026-09-03

    Scope: integration, deployment, monitoring, productFamilyContext

Research history

  1. K232322 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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