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TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM - P2

by Toshiba America Medical Systems, In.C

510(k) K032490

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 · Traditional NumberK032490 Date21 Aug 2003ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2278-2012 FDA Class II initiated 13 May 2008

    The status display in the sequence queue window may not change from "Current" to "Done".

    • Terminated Z-0281-06 FDA Unclassified (pre-2012) initiated 12 Oct 2005

    To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.

    • Terminated Z-0061-05 FDA Unclassified (pre-2012) initiated 16 Sep 2004

    Scanned images are acquired at a position that is shifted relative to the intended position in the slice direction due to a software anomaly.

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  • Withdrawn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
Models / Variants
P2
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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