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MRT-50A Super

by Toshiba America Mri, Inc.

510(k) K924808

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 NumberK924808 Date27 Apr 1993ClearedStatusActive

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  • Withdrawn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, 27 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 Mrt-50a Super is a nuclear magnetic resonance imaging system. It is classified as a Class II medical device used in the field of radiology.

This device is authorized for use under FDA 510(k) clearance K924808. It is manufactured by Toshiba America Mri, Inc.

Other devices from Toshiba America Mri, Inc.

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Questions

AI-generated answers, 27 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 use of the MRT-50A Super?

    The MRT-50A Super is a nuclear magnetic resonance imaging system designed for use within the field of radiology to assist in diagnostic imaging procedures.

  • What is the regulatory status of this device?

    This device is authorized for use under FDA 510(k) clearance K924808, which was granted on April 27, 1993.

  • Who is the manufacturer of the MRT-50A Super?

    The device is manufactured by Toshiba America Mri, Inc., located in South San Francisco, California.