Skip to content

Msk Extreme MR Scanner, Model AA5000

by Oni Medical Systems, Inc.

510(k) K080048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK080048 Date6 Feb 2008ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-1927-2016 FDA Class II initiated 9 May 2016

    The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.

    • Terminated Z-1211-2013 FDA Class II initiated 28 Mar 2013

    Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

    • Terminated Z-0107-2012 FDA Unclassified (pre-2012) initiated 29 Aug 2011

    GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock, which may impact service personnel safety. This issue does not impact patient or operator safety.

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  • Withdrawn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