MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

Evidence summary

The exact FDA decision material describes the MAGNETOM Flow.Ace and Flow.Plus systems, optional coils, head, body, and extremity imaging, and standard physician interpretation. It does not establish a universal clinical sensitivity or specificity claim.

FDA source Exact FDA submission Checked 2026-09-04

• Source

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

Postmarket safety review

The 2026-09-02 openFDA device-recall snapshot contained no record matched to K260265 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.

Public source Exact FDA submission Checked 2026-09-04

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

• Source

• Verify DICOM, HL7/FHIR, PACS/RIS/EHR integration: The public exact-submission material does not establish a complete integration contract. Confirm DICOM, worklist, identity, interfaces, exports, routing, audit behavior, and downtime locally.
• Verify deployment and data flow: The public exact-submission 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 hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

This submission was added after the prior exact-submission extraction and remains queued for source review. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K260265; review status is candidate_review_pending. Any candidate literature or registry record remains quarantined as product-family evidence unless exact submission and version linkage is established. Current vendor material is product-family context. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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 material, vendor product page, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

• FDA 510(k) decision material K260265: MAGNETOM Flow.Ace; MAGNETOM Flow.Plus U.S. Food and Drug Administration · 2026-09-04
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• Siemens MAGNETOM MRI family Siemens Healthineers · 2026-09-04