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Optima MR450W

by Ge Healthcare (Ge Medical Systems, LLC)

510(k) K123522

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK123522 Date13 Mar 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-3024-2017 FDA Class II initiated 11 May 2017

    Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

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  • Withdrawn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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