MAGNETOM Sola - MAGNETOM Flow.Neo
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252838 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
- Models / Variants
- MAGNETOM Sola FDA 510(k)MAGNETOM Altea FDA 510(k)MAGNETOM Sola Fit FDA 510(k)MAGNETOM Viato.Mobile FDA 510(k)MAGNETOM Vida FDA 510(k)MAGNETOM Lumina FDA 510(k)MAGNETOM Vida Fit FDA 510(k)MAGNETOM Flow.Elite FDA 510(k)MAGNETOM Flow.Neo FDA 510(k)MAGNETOM Flow.Rise FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MAGNETOM series comprises magnetic resonance imaging (MRI) systems designed for diagnostic imaging. These devices generate transverse, sagittal, coronal, and oblique cross-sectional images using magnetic resonance technology, enabling detailed visualization of internal body structures for clinical assessment.
These systems are intended for use in radiology departments and are supplied with software versions such as Syngo MR XB10. They are classified under product code LNH and have received FDA 510(k) clearance as substantially equivalent to predicate devices. The devices are not single-use and are regulated under traditional clearance pathways, with no third-party review involved.
Frequently asked questions
What types of MRI images can the MAGNETOM series generate, and how might this benefit clinical assessments?
The MAGNETOM series generates transverse, sagittal, coronal, and oblique cross-sectional images using magnetic resonance technology. This capability allows clinicians to visualize internal body structures in multiple planes, improving diagnostic accuracy for conditions requiring detailed anatomical assessment, such as soft tissue evaluation, neurological disorders, or musculoskeletal injuries.
Are these MRI systems intended for single-use or repeated use in clinical settings?
The MAGNETOM series is designed for repeated use in radiology departments, not single-use. This makes them cost-effective for high-volume imaging environments where durability and long-term reliability are essential.
What software version is included with the MAGNETOM MRI systems, and how might this affect workflow?
The MAGNETOM systems are supplied with Syngo MR XB10 software, which integrates imaging acquisition, post-processing, and reporting tools. This streamlines workflow by providing a unified platform for radiologists to capture, analyze, and share diagnostic images efficiently.
How are these devices regulated, and what does the FDA 510(k) clearance indicate about their safety and performance?
The MAGNETOM series received FDA 510(k) clearance under product code LNH, with a decision of *substantially equivalent* to predicate devices. This means the FDA determined the systems meet the same performance standards as previously approved MRI systems, ensuring they are safe and effective for their intended use in radiology departments.
What is the regulatory pathway for these devices, and does it involve third-party review?
The MAGNETOM series is regulated under the traditional FDA 510(k) clearance pathway, which does not require third-party review (as indicated by the *third_party_flag: N*). This means Siemens Healthcare GmbH submitted the data directly to the FDA for evaluation by their own review panel (Radiology Advisory Committee).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile ..., PDF December 19, 2025 Siemens Healthcare GmbH ℅ Alina Goodman Regulatory ..., MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile ..., MAGNETOM Sola Fit - Siemens Healthineers USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252838 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K252838 24 fields · synced Oct 6, 2026