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Excelart

by Toshiba America Mri, Inc.

510(k) K990620

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK990620 Date14 May 1999ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0986-05 FDA Unclassified (pre-2012) initiated 25 May 2005

    Patient information A is displayed with images for patient B.

    • Terminated Z-0270-05 FDA Unclassified (pre-2012) initiated 6 Oct 2004

    Software defect causes images to be rotated 180 degrees.

    • Terminated Z-1045-04 FDA Unclassified (pre-2012) initiated 7 Jun 2004

    Wrong positioning may cause patient burns.

    • Terminated Z-0937-04 FDA Unclassified (pre-2012) initiated 6 May 2004

    Software anomaly.

    • Terminated Z-0546-04 FDA Unclassified (pre-2012) initiated 27 Jan 2004

    Software anomally causes image slices to be in incorrect order.

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  • Withdrawn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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