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GE 0.35T Signa Ovation with Excite MR System

by General Electric Co.

510(k) K033504

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 · Special NumberK033504 Date25 Nov 2003ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0693-2019 FDA Class II initiated 15 Nov 2018

    Possible incorrect software version loaded.

    • Terminated Z-0426-2011 FDA Unclassified (pre-2012) initiated 23 Aug 2010

    If the lateral table adjustment crank handle breaks off, it has sufficient attractive force to the magnet and may result in patient injury.

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  • Withdrawn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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