Electron Arc Therapy

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

510(k) Number

K802809 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Bds-3 Beam Data Scanner

  Class I

  FDA 510(k) K844620 Active Cleared 1 Jul 1985

• Flouroscope, Mobile C-Arm Image Intens.

  Class II

  FDA 510(k) K760429 Active Cleared 23 Aug 1976

• Spectrophotometer Analysis Sys.

  Class I

  FDA 510(k) K771807 Active Cleared 28 Nov 1977

• Applicators for Varian Varisource Remote High Dose Rate Afterloader

  Class II

  FDA 510(k) K955844 Active Cleared 26 Jul 1996

• Spectrophotometer Analysis Sys., Aa-175

  Class I

  FDA 510(k) K770443 Active Cleared 8 Apr 1977

• Electron Beam Option for Clinac 15 Mev

  Class II

  FDA 510(k) K832502 Active Cleared 12 Sep 1983

See all devices from Varian Assoc., Inc. →

• What is the primary purpose of the Electron Arc Therapy device, and how does it differ from standard radiation therapy methods?

  The Electron Arc Therapy device is designed to deliver electron beam radiation therapy with a rotating beam (arc technique), allowing precise targeting of malignant tissues while minimizing exposure to surrounding healthy tissue. Unlike traditional static radiation therapy, this system ensures a more uniform dose distribution around the tumor by continuously rotating the beam, which can improve treatment accuracy and reduce side effects.

• Is the Electron Arc Therapy device reusable, and if so, what maintenance considerations should be taken into account?

  Yes, the Electron Arc Therapy device is reusable and non-sterile, meaning it is intended for repeated use within a radiology setting. Since it is not sterile, proper cleaning, calibration, and maintenance protocols must be followed to ensure safety, accuracy, and compliance with regulatory standards. The manufacturer’s instructions should be consulted for specific maintenance guidelines.

• What regulatory pathway was followed for the approval of this device, and what classification does it hold?

  The Electron Arc Therapy device received FDA 510(k) clearance under the traditional review pathway, classified as Device Class II under regulation number 892.5050. The submission was reviewed by the Radiology (RA) Advisory Committee, and the device was determined to be substantially equivalent to a predicate device, allowing it to enter the market with this classification.

• Does this device require any special handling or storage conditions beyond standard medical equipment?

  The regulatory data does not specify any special sterility, MRI safety, or unique storage requirements beyond typical radiology equipment standards. Since it is reusable and non-sterile, it should be stored in a clean, controlled environment to prevent contamination and ensure proper functionality. Always follow the manufacturer’s guidelines for setup and maintenance.