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Mrt-50GP

by Toshiba America Mri, Inc.

510(k) K933018

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK933018 Date18 Feb 1994ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0937-04 FDA Unclassified (pre-2012) initiated 6 May 2004

    Software anomaly.

    • Terminated Z-0546-04 FDA Unclassified (pre-2012) initiated 27 Jan 2004

    Software anomally causes image slices to be in incorrect order.

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  • Withdrawn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

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