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Magniscan 5000 MRI System

by Thomson-Cgr Medical Corp.

PMA P850043

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P850043↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP850043 Date29 Dec 1987ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
System, nuclear magnetic resonance imaging
PMA Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
APPR Approved
PMA Supplement
S002 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Magniscan 5000 MRI System is a nuclear magnetic resonance imaging system designed for diagnostic radiology. It generates detailed images of internal body structures using strong magnetic fields and radio waves, enabling non-invasive visualization of organs, tissues, and abnormalities for clinical assessment.

This system is intended for use in radiology departments within healthcare facilities, supplied as a reusable medical device. It operates in MRI-compatible environments and requires proper installation, calibration, and maintenance to ensure safe and accurate imaging. The device holds an FDA Premarket Approval (PMA) under the classification of Class II (LNH product code) and is regulated under 21 CFR 892.1000.

Other devices from Thomson-Cgr Medical Corp.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the MAGNISCAN 5000 MRI System in a clinical setting?

    The MAGNISCAN 5000 MRI System is designed for diagnostic radiology to generate detailed images of internal body structures using strong magnetic fields and radio waves. This allows clinicians to visualize organs, tissues, and abnormalities non-invasively, aiding in clinical assessment and diagnosis.

  • Is the MAGNISCAN 5000 MRI System intended for single-use or reusable applications?

    The MAGNISCAN 5000 MRI System is explicitly described as a reusable medical device. It requires proper installation, calibration, and maintenance to ensure safe and accurate imaging in MRI-compatible environments.

  • What regulatory pathway does the MAGNISCAN 5000 MRI System follow, and what does this mean for its use?

    The MAGNISCAN 5000 MRI System holds an FDA Premarket Approval (PMA) under product code LNH, classified as Class II. This means it has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in radiology departments within healthcare facilities.

  • How is the MAGNISCAN 5000 MRI System supplied, and what should be considered for its storage?

    The device is supplied as a reusable system, meaning it is not packaged individually for single-use. Since it is a high-field MRI system, it must be installed in a dedicated MRI-compatible environment. Storage considerations include proper maintenance, calibration, and adherence to manufacturer guidelines to ensure optimal performance and safety.