Siemens Mevatron ME

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K852907 ↗

FDA Product Code

LHN

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 Siemens Mevatron ME used for?

  The Siemens Mevatron ME is a Radiation Therapy, Charged-Particle Medical System designed to accelerate high-energy charged particles (such as electrons and protons) for targeted radiation treatment. It is primarily used in oncology to treat malignant tumors by delivering precise radiation doses with deeper tissue penetration and reduced collateral damage to surrounding healthy tissue compared to conventional photon-based radiotherapy.

• Is the Siemens Mevatron ME a single-use or reusable device?

  The Siemens Mevatron ME is a reusable medical system. It is intended for installation in radiology departments within hospital or clinical settings and requires proper maintenance by trained personnel to ensure safe and compliant operation.

• What regulatory clearance does the Siemens Mevatron ME hold?

  The Siemens Mevatron ME holds FDA 510(k) clearance (K852907) under the Radiology Device Advisory Committee, with a decision date of September 19, 1985. It was determined to be substantially equivalent to a legally marketed predicate device, classified as a Class II medical device.

• How is the Siemens Mevatron ME supplied and maintained?

  The Siemens Mevatron ME is supplied as a complete reusable system for installation in radiology departments. It requires proper installation, calibration, and ongoing maintenance by trained personnel to ensure safe operation and compliance with regulatory standards. The device is not designated as sterile or single-use.

• What types of charged particles does the Siemens Mevatron ME accelerate?

  The Siemens Mevatron ME accelerates high-energy charged particles, specifically electrons and protons, for use in radiation therapy. This technology allows for deeper penetration of radiation into target tissues while minimizing exposure to adjacent healthy tissue.