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Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System, Model 4000451-51

by Sentinelle Medical, Inc.

510(k) K100113

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 · Special NumberK100113 Date22 Apr 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2688-2016 FDA Class II initiated 6 May 2016

    A diode was inadvertently not assembled into the system, which may result in coil overheating

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  • Withdrawn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
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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