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Easy Moving Mobile X-Ray Unit (Model Sm-Hf)

by Sedecal USA, Inc.

510(k) K012663

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 NumberK012663 Date31 Aug 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-650/51-03 FDA Unclassified (pre-2012) initiated 26 Sep 2002 on shared 510(k) K012663

    Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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