VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE

K964138 · Varian Medical Systems, Inc. · KPQ · Jan 10, 1997 · Radiology

Device Facts

• Record ID: K964138
• Device Name: VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
• Applicant: Varian Medical Systems, Inc.
• Product Code: KPQ · Radiology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2

Indications for Use

The Ximatron Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.

Device Story

Ximatron C-Series Radiation Therapy Simulator; gantry-mounted x-ray tube, collimator, image intensifier, rotatable cassette holder. Controlled via console, hand pendants, or couch-side panels. Version 4.2 software adds Dynamic Motion Management (DMM) for collision avoidance; Delta GoTo; Auto Tracking with Fluoro; Mouse-based interface. Used in clinical radiation therapy departments by physicians/technicians. DMM uses selectable patient volume parameters to prevent mechanical collisions. Output: fluoroscopic/radiographic images for treatment planning and field verification. Benefits: improved safety via collision prevention and enhanced workflow efficiency through automated tracking and navigation features.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Gantry-based x-ray simulator; fluoroscopic/radiographic imaging; software-controlled mechanical motion. Features: Dynamic Motion Management (DMM) for collision avoidance, Auto Tracking, Delta GoTo. Version 4.2 software.

Indications for Use

Indicated for patients requiring radiation therapy simulation to visualize treatment volumes and confirm therapeutic irradiation field positioning and sizing.

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Varian Ximatron C-Series Radiation Therapy Simulator (K853349)

Submission Summary (Full Text)

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JAN 10 1997
K964/38

Summary of
Safety and Effectiveness
Information

1. Submitter: Varian Oncology Systems
3045 Hanover Street
Palo Alto, CA 94304

Contact: Charles H. Will, Manager
Regulatory Compliance & Safety
Phone [phone]
FAX [phone]
[e-mail]

Prepared: October 11, 1996

2. Device Name: Varian Ximatron C-Series Radiation Therapy Simulator
with Version 4.2 Software

3. Predicate Device: Varian Ximatron C-Series Radiation Therapy Simulator,
cleared October 28, 1985, 510(k) No. K853349

4. Description: The Varian Ximatron C-Series Radiation Therapy Simulator
consists of a stand that supports a gantry and houses various
electronic support functions. The gantry houses an x-ray tube
housing assembly and supports a collimator and image
intensifier with a rotatable cassette holder. Mechanical motions
of the Ximatron can be controlled from the control console or
hand pendants in the simulator room. The patient couch can
also be controlled from side panel controls mounted on the
couch.

5. Intended Use: The Ximatron Radiation Therapy Simulator is to be used in
radiation therapy simulation, using a fluoroscopic and/or
radiographic x-ray system for visualizing the volume to be
exposed during radiation therapy and confirming the position and
size of the therapeutic irradiation field to be applied.

6. Technological Considerations: The Ximatron simulator reported in this 510(k) is substantially
equivalent to the device reported in the prior 510(k). It includes
a software controlled feature, Dynamic Motion Management
(DMM), which prevents any mechanical part of the Ximatron
from colliding with any other part, taking into account a volume,
selectable by size, to include the patient. Also included are
Delta GoTo, Auto Tracking with Fluoro, and Mouse features.