Focus Radiation Treatment Planning System

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

510(k) Number

K020027 ↗

FDA Product Code

MUJ

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Focus

  Class II

  FDA 510(k) K002147 Active Cleared 13 Oct 2000

• Monaco Rtp System

  Class II

  FDA 510(k) K110730 Active Cleared 24 Jun 2011

• Enhanced Compensating Filter

  Class II

  FDA 510(k) K000137 Active Cleared 17 Apr 2000

• Focus Rtp System

  Class II

  FDA 510(k) K973936 Active Cleared 1 Jun 1998

• I-Beam

  Class II

  FDA 510(k) K032100 Active Cleared 2 Oct 2003

• Record and Verify Mevatron Adapter

  Class II

  FDA 510(k) K913674 Active Cleared 22 Nov 1991

See all devices from Computerized Medical Systems, Inc. →

• What is the primary purpose of the Focus Radiation Treatment Planning System and how does it assist clinicians in radiation therapy?

  The Focus Radiation Treatment Planning System is a software-based tool designed to help clinicians create precise treatment plans for radiation therapy. It uses advanced computational algorithms to optimize dose distribution, improve target localization, and implement organ-sparing strategies. This ensures that radiation is delivered accurately to tumor sites while minimizing exposure to healthy tissue, which is critical for external beam radiotherapy and charged-particle therapy.

• Is the Focus Radiation Treatment Planning System a standalone product, or does it require additional hardware to function?

  The Focus Radiation Treatment Planning System is supplied as a software solution and requires compatible hardware for execution. It is not a standalone physical device but must be installed on appropriate radiation oncology department systems to operate effectively.

• How is the Focus Radiation Treatment Planning System intended to be used in clinical settings, and what are its reuse or single-use considerations?

  The system is intended for single-use per treatment plan, meaning each new treatment plan calculation is considered a distinct session. However, the underlying software itself is reusable across multiple treatment sessions, as it is not consumed or discarded after a single use. It operates in non-sterile environments and does not require sterility, as it does not interact with sterile procedures.

• What regulatory pathway was followed for the FDA clearance of the Focus Radiation Treatment Planning System, and what class does it fall under?

  The Focus Radiation Treatment Planning System was granted FDA 510K clearance through a traditional review pathway, classified as a Class II device. The clearance was based on a determination of substantial equivalence to a predicate device, and the system was reviewed by the Radiology (RA) Advisory Committee.

• Does the Focus Radiation Treatment Planning System have any specific safety considerations related to MRI environments or magnetic fields?

  No, the Focus Radiation Treatment Planning System does not interact directly with magnetic fields or MRI environments. The device description explicitly states there are no MRI safety or sterility requirements for the software itself, as it is designed for use in non-sterile, non-magnetic environments.