MEVATRON 67E

• • Terminated Z-1434-2017 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.

510(k) Number

K812032 ↗

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

See all devices from Siemens Medical Laboratories, Inc. →

• What is the MEVATRON 67E used for?

  The MEVATRON 67E is designed for use in radiology settings to deliver therapeutic radiation, as it is a linear accelerator intended for medical applications involving radiation treatment.

• Is the MEVATRON 67E a single-use device?

  The MEVATRON 67E is not a single-use device, as explicitly stated in the device data, meaning it is intended for repeated use after appropriate cleaning and maintenance between procedures.

• How was the MEVATRON 67E cleared for market?

  The MEVATRON 67E received FDA 510(k) clearance through a traditional review process, with the decision date of August 18, 1981, and K-number K812032, indicating it was found substantially equivalent to a legally marketed predicate device.