36-101 XDS111 Xenon Delivery/Trap System

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K860504 ↗

FDA Product Code

ITY

Device Class

Class I

Regulation

21 CFR Part 892.1760

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K934850 Active Cleared 22 Nov 1993

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  Class II

  FDA 510(k) K792591 Active Cleared 4 Jan 1980

• Radioisotope Calibrator Model 34-062

  Class II

  FDA 510(k) K850815 Active Cleared 21 Aug 1985

• Dynamic Cardiac Phantom 74-347

  Class I

  FDA 510(k) K853756 Active Cleared 29 Oct 1985

• Veridose Diodes

  Class II

  FDA 510(k) K964785 Active Cleared 13 Jun 1997

• Nuclear Associates Model 34-070 Brachytherapy Cal.

  Class II

  FDA 510(k) K931657 Active Cleared 27 Jul 1993

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