Fonar NMR Whole Body Scanner Beta 3000

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

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P830076 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S003

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• What is the primary purpose of the Fonar NMR Whole Body Scanner Beta 3000 in a clinical setting?

  The Fonar NMR Whole Body Scanner Beta 3000 is designed to generate high-contrast, detailed cross-sectional images of the human body using nuclear magnetic resonance (NMR) technology. This enables radiologists to evaluate soft tissues, organs, and skeletal structures for diagnostic purposes, such as identifying abnormalities, tumors, or structural anomalies.

• Is the Fonar NMR Whole Body Scanner Beta 3000 approved for use in hospitals or other clinical environments?

  Yes, the device is authorized under FDA Premarket Approval (PMA) with PMA number P830076 and subsequent supplements. It is classified as a Class II medical device under FDA regulation 892.1000 and is intended for use in radiology departments within clinical settings, such as hospitals.

• How is the Fonar NMR Whole Body Scanner Beta 3000 regulated, and what does that mean for its use?

  The scanner falls under the FDA’s regulatory classification for nuclear magnetic resonance imaging systems (product code LNH) and requires compliance with standard MRI safety protocols, including electromagnetic interference mitigation and shielding. Its approval status ensures it meets FDA standards for diagnostic imaging, but its use must adhere to established MRI safety guidelines to protect patients and staff.

• Are there different models or configurations of the Fonar NMR Whole Body Scanner Beta 3000, or is it a single unified system?

  The provided data does not specify multiple models or configurations for the Beta 3000. It is described as a singular nuclear magnetic resonance imaging system, though it may include various software updates or technical enhancements as part of its authorized supplements. For exact specifications, consulting the manufacturer’s documentation or support resources would be advisable.

• What safety or handling considerations should be taken into account when storing or operating the Fonar NMR Whole Body Scanner Beta 3000?

  While the data does not detail specific storage conditions, MRI systems like the Beta 3000 require adherence to standard protocols for electromagnetic interference mitigation, shielding, and environmental controls to maintain performance and safety. Proper calibration, routine maintenance, and compliance with manufacturer guidelines are essential to ensure reliable operation and patient safety.