Trans X-1000

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K945635 ↗

FDA Product Code

KPX

Device Class

Class II

Regulation

21 CFR Part 892.1860

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K843021 Active Cleared 5 Oct 1984

• Canon X-Ray Image Distributor

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  FDA 510(k) K853984 Active Cleared 16 Oct 1985

• Optional Probe of Canon IOL Estimator Ku-1

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  Class II

  FDA 510(k) K033624 Active Cleared 15 Dec 2003

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  Class I

  FDA 510(k) K853861 Active Cleared 24 Oct 1985

See all devices from Canon USA, Inc. →