Applicators for Varian Varisource Remote High Soes Rate Afterloader

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

510(k) Number

K952913 ↗

FDA Product Code

JAQ

Device Class

Class II

Regulation

21 CFR Part 892.5700

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 use of these applicators in radiation therapy?

  These applicators are designed as part of a remote-controlled radionuclide system for radiation brachytherapy. They deliver high specific activity radioisotope sources to targeted tissue, enabling precise and controlled radiation delivery in clinical settings. This setup minimizes operator exposure time while ensuring accurate treatment of the intended area.

• Are these applicators sterile and single-use, or reusable?

  The applicators are non-sterile and reusable. They are intended for use by trained radiology personnel within a regulated medical device system, adhering to FDA clearance under 510(k) number K952913. Reusability is maintained through adherence to strict radiation safety protocols and proper handling procedures.

• How do I determine compatibility with my Varian Varisource system?

  Compatibility is ensured through multiple model references associated with these applicators. Each reference corresponds to specific configurations of the Varian Varisource Remote High Dose Rate Afterloader system. Consult the manufacturer’s documentation or technical support to confirm the exact model required for your setup.

• What safety protocols should be followed for storage and handling?

  Storage and handling must follow standard radiation safety protocols to maintain device integrity and operational readiness. This includes proper shielding, secure storage to prevent contamination or damage, and adherence to institutional radiation safety guidelines. Always refer to the manufacturer’s instructions for detailed procedures.

• What regulatory clearance applies to these applicators?

  These applicators are cleared under FDA 510(k) number K952913 and fall under regulation 892.5700. The clearance is classified as substantially equivalent (SESE) and was reviewed by the Radiology (RA) Advisory Committee. They are intended for use within a remote-controlled radionuclide system setup.