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Dua-900A Image-Intensified Fluoroscopic X-Ray Syst

by Toshiba America Medical Systems, In.C

510(k) K922364

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 NumberK922364 Date4 Sep 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1675-2011 FDA Unclassified (pre-2012) initiated 15 Jul 2010

    Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement.

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  • Withdrawn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
IXR
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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