Mevatron 67

• • Terminated Z-1433-2017 FDA Class II ·initiated 25 Jan 2017

  Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is possible for the weld seam to break and to cause the overhead suspension to fall down. This can lead to a severe injury to a patient or any other person.

• • Terminated Z-2174-2014 FDA Class II ·initiated 28 May 2014

  A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.

510(k) Number

K790688 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• 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 60

  Class II

  FDA 510(k) K790388 Active Cleared 26 Mar 1979

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