Beamview & Beamview Plus (Aka Project 743)

• • Terminated Z-2635-2011 FDA Unclassified (pre-2012) ·initiated 4 Nov 2010

  The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis.

510(k) Number

K903139 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mevatron, M 2 Class

  Class II

  FDA 510(k) K882729 Active Cleared 19 Sep 1988

• Z Xt Radiation Therapy Treatment Table

  Class II

  FDA 510(k) K910971 Active Cleared 3 May 1991

• Sonoline Cf

  Class II

  FDA 510(k) K875272 Active Cleared 18 Feb 1988

• Mevatron 74X Medical Linear Accelerator

  Class II

  FDA 510(k) K791967 Active Cleared 16 Nov 1979

• Mevatron Kd-2

  Class II

  FDA 510(k) K862339 Active Cleared 29 Oct 1986

• Mevatron 67

  Class II

  FDA 510(k) K790688 Active Cleared 23 Apr 1979

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