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MRT 50A

by Toshiba America Mri, Inc.

510(k) K903770

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK903770 Date20 Nov 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The MRT 50A is a Nuclear Magnetic Resonance Imaging System, classified as a Class II medical device under product code LNH. It generates detailed images of the internal structures of the body using strong magnetic fields and radio waves, primarily for diagnostic radiology applications such as soft tissue contrast imaging, musculoskeletal assessment, and neurological evaluation.

This device is intended for use in radiology departments within healthcare facilities and is designed for single-patient imaging sessions. Supplied as a reusable system, it requires proper maintenance and calibration to ensure MRI safety compliance, including adherence to strict electromagnetic interference (EMI) and radiofrequency (RF) guidelines. The MRT 50A operates within a controlled environment and is regulated under FDA clearance (K903770) via the Traditional 510(k) pathway, with a decision date of November 20, 1990.

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Questions

AI-generated answers, 1 Oct 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 use of the Toshiba MRT 50A MRI System?

    The MRT 50A is designed for diagnostic radiology applications, specifically to generate detailed images of internal body structures using magnetic fields and radio waves. Its primary uses include soft tissue contrast imaging, musculoskeletal assessment, and neurological evaluation, enabling precise diagnostic insights for clinicians.

  • Is the MRT 50A intended for single-patient or multi-patient use?

    The MRT 50A is intended for single-patient imaging sessions. This design ensures focused attention on individual diagnostic needs while maintaining the system’s performance and safety standards within radiology departments.

  • How is the MRT 50A supplied and maintained?

    The MRT 50A is supplied as a reusable system, requiring regular maintenance and calibration to ensure MRI safety compliance. This includes adherence to electromagnetic interference (EMI) and radiofrequency (RF) guidelines, as well as proper upkeep of its magnetic and radio wave components to sustain optimal imaging quality.

  • What regulatory pathway was followed for the MRT 50A?

    The MRT 50A was cleared through the FDA’s Traditional 510(k) pathway, with a decision date of November 20, 1990. It was classified as substantially equivalent under product code LNH, ensuring compliance with U.S. medical device regulations for nuclear magnetic resonance imaging systems.

  • Does the MRT 50A require special storage conditions?

    While the device itself is not single-use, its controlled environment operation means it must be stored in a dedicated radiology space free from magnetic interference. Proper calibration and maintenance protocols must also be followed to preserve its performance and safety standards over time.