NMR Imaging System

No FDA recalls on record, checked 22 Oct 2026.

Full name

Diasonics Nmr Imaging System

Trade Name

Diasonics Mt/S (Magnetic Tomography/Superconductin

Generic Name

System, nuclear magnetic resonance imaging

PMA Number

P830053 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

APPR Approved

PMA Supplement

S001

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See all devices from Diasonics, Inc. →

• What is the primary purpose of the DIASONICS NMR Imaging System in a clinical setting?

  The DIASONICS NMR Imaging System is designed to generate detailed images of internal human structures using magnetic fields and radio waves, enabling non-invasive visualization of soft tissues, organs, and abnormalities. This makes it particularly useful for diagnostic purposes in radiology, allowing clinicians to identify and assess conditions without surgery or invasive procedures.

• Is the DIASONICS NMR Imaging System intended for single-use or repeated use in a clinical environment?

  The DIASONICS NMR Imaging System is supplied as a reusable device. Since it is classified as a Class II medical device, it requires proper maintenance, calibration, and adherence to regulatory standards to ensure accurate and reliable imaging performance over multiple uses.

• What regulatory pathway was followed for the approval of the DIASONICS NMR Imaging System in the United States?

  The DIASONICS NMR Imaging System received FDA Premarket Approval (PMA) under the designation P830053. This approval process ensures that the device meets the FDA’s stringent requirements for safety and effectiveness before being authorized for distribution in the U.S.

• How is the DIASONICS NMR Imaging System categorized in terms of medical specialty and regulatory classification?

  The system falls under the medical specialty of Radiology and is classified as a Class II medical device by the FDA. This classification reflects its role in diagnostic imaging, where it aids in the visualization of internal structures for clinical assessment.

• What specific regulatory standards does the DIASONICS NMR Imaging System adhere to?

  The system adheres to regulatory standards outlined under the regulation number 892.1000, which governs nuclear magnetic resonance (NMR) imaging devices. This ensures compliance with FDA requirements for design, performance, and safety in clinical use.