MAGNETOM Avanto Fit - MAGNETOM Skyra Fit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250443 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
- Models / Variants
- MAGNETOM Avanto Fit FDA 510(k)MAGNETOM Skyra Fit FDA 510(k)MAGNETOM Sola Fit FDA 510(k)MAGNETOM Viato.Mobile 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 Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile are Nuclear Magnetic Resonance Imaging (MRI) Systems designed for high-resolution diagnostic imaging. These devices utilize magnetic resonance technology to generate detailed images of internal body structures, including soft tissues, organs, and skeletal systems, enabling accurate diagnosis of conditions such as tumors, neurological disorders, and musculoskeletal injuries. Each model incorporates advanced acceleration techniques and deep-learning reconstruction algorithms to enhance image quality and reduce scan times while maintaining diagnostic precision.
These MRI systems are intended for use in clinical radiology settings and are supplied as reusable medical devices. They are not single-use and require proper maintenance, calibration, and adherence to MRI safety protocols, including shielding against metallic objects and compliance with electromagnetic interference standards. The devices are authorized under FDA 510(k) clearance and classified under Device Class II (892.1000), with multiple registration numbers listed in the OpenFDA database. They are designed for integration into hospital or specialized imaging centers, where trained personnel operate them under regulatory oversight.
Frequently asked questions
Are these MRI systems designed for single-use or reusable in clinical settings?
The MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile are reusable medical devices. They require proper maintenance, calibration, and adherence to MRI safety protocols, including shielding against metallic objects and compliance with electromagnetic interference standards, as they are intended for integration into hospital or specialized imaging centers.
What types of diagnostic imaging capabilities do these MRI systems provide?
These MRI systems generate high-resolution diagnostic images of internal body structures, including soft tissues, organs, and the skeletal system. They are specifically designed to aid in diagnosing conditions such as tumors, neurological disorders, and musculoskeletal injuries, leveraging advanced acceleration techniques and deep-learning reconstruction algorithms for enhanced image quality and reduced scan times.
How are these MRI systems regulated in the U.S. market?
The devices are authorized under FDA 510(k) clearance and classified under Device Class II (892.1000). They were determined to be substantially equivalent to a predicate device through a traditional review process, as indicated by the decision code *SESE* (Substantially Equivalent). The submission was filed under the Radiology advisory committee (RA).
What environments are these MRI systems intended for?
These systems are designed exclusively for clinical radiology settings, such as hospitals or specialized imaging centers. They require trained personnel to operate under regulatory oversight, ensuring compliance with MRI safety protocols and electromagnetic interference standards.
How many unique registration numbers are associated with these MRI systems in the OpenFDA database?
The MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile have multiple registration numbers listed in the OpenFDA database, totaling 58 distinct FEI numbers (e.g., 3008156140, 3021593788, etc.). These correspond to various models and configurations of the systems.
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 Avanto Fit - Siemens Healthineers, Options & Upgrades - Get the most from your investment - Siemens ..., PDF siemens.com/avanto-fit MAGNETOM Avanto fit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250443 | Class II | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
Sources (1)
- FDA 510(k) K250443 24 fields · synced Oct 6, 2026