Magnetom

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P830081 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S005

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• What types of medical facilities typically use the Magnetom System, and who operates it?

  The Magnetom System is designed for use in radiology departments and clinical imaging centers. It is operated by trained radiologic technologists or medical physicists, who are specially trained to manage MRI equipment and ensure safe, accurate imaging procedures.

• Is the Magnetom System reusable or single-use, and what safety protocols must be followed?

  The Magnetom System is a reusable medical device. Due to its strong magnetic field, it requires strict compliance with MRI safety protocols to ensure patient and staff safety, including proper screening for metallic implants or foreign objects.

• What regulatory pathway was followed for the Magnetom System’s approval, and what does this mean for its use?

  The Magnetom System was authorized under the FDA’s Premarket Approval (PMA) pathway, specifically PMA P830081. This means it underwent rigorous review to demonstrate safety and effectiveness for its intended use as a nuclear magnetic resonance imaging (NMRI) device, ensuring it meets stringent regulatory standards for diagnostic imaging.

• What medical specialties primarily utilize the Magnetom System for imaging?

  The Magnetom System is categorized under the medical specialty of Radiology, making it suitable for diagnostic imaging across various clinical assessments, including soft tissue, organs, and skeletal systems, as part of routine radiologic evaluations.

• How many different models or configurations of the Magnetom System have been registered with regulatory authorities?

  The Magnetom System includes multiple registered configurations, as indicated by the extensive list of FEI numbers (e.g., 3008156140, 3021593788, etc.). These variations may correspond to different technical specifications, software updates, or hardware revisions, all of which have been formally registered under the same PMA.