(87 days)
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.
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.
This document describes a medical device submission (K9641/38) for the Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software.
Based on the provided information, the device is a radiation therapy simulator, and the submission is for a new software version (4.2) which includes features like Dynamic Motion Management (DMM), Delta GoTo, Auto Tracking with Fluoro, and Mouse features. The submission claims substantial equivalence to a previously cleared device (K853349).
However, the provided text does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study to prove it, as this information is not present in the given summary.
The summary focuses on:
- The submitter and contact information.
- The device name and software version.
- The predicate device.
- A description of the device's hardware components and how it's controlled.
- Its intended use (radiation therapy simulation).
- New technological considerations (software features like DMM).
To answer your questions, I would need a different document, likely one detailing a clinical performance study or validation testing for the software features.
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K9641/38
Summary of Summary of Information
JAN | 0 1997
| 1. Submitter: | Varian Oncology Systems3045 Hanover StreetPalo Alto, CA 94304 |
|---|---|
| Contact: Charles H. Will, ManagerRegulatory Compliance & SafetyPhone (415) 424-5036FAX (415) 424-4830cwill@os.varian.com | |
| Prepared: October 11, 1996 | |
| 2. Device Name: | Varian Ximatron C-Series Radiation Therapy Simulatorwith Version 4.2 Software |
| 3. PredicateDevice: | Varian Ximatron C-Series Radiation Therapy Simulator,cleared October 28, 1985, 510(k) No. K853349 |
| 4. Description: | The Varian Ximatron C-Series Radiation Therapy Simulatorconsists of a stand that supports a gantry and houses variouselectronic support functions. The gantry houses an x-ray tubehousing assembly and supports a collimator and imageintensifier with a rotatable cassette holder. Mechanical motionsof the Ximatron can be controlled from the control console orhand pendants in the simulator room. The patient couch canalso be controlled from side panel controls mounted on thecouch. |
| 5. Intended Use: | The Ximatron Radiation Therapy Simulator is to be used inradiation therapy simulation, using a fluoroscopic and/orradiographic x-ray system for visualizing the volume to beexposed during radiation therapy and confirming the position andsize of the therapeutic irradiation field to be applied. |
| 6.TechnologicalConsiderations: | The Ximatron simulator reported in this 510(k) is substantiallyequivalent to the device reported in the prior 510(k). It includesa software controlled feature, Dynamic Motion Management(DMM), which prevents any mechanical part of the Ximatronfrom colliding with any other part, taking into account a volume,selectable by size, to include the patient. Also included areDelta GoTo, Auto Tracking with Fluoro, and Mouse features. |
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§ 892.5840 Radiation therapy simulation system.
(a)
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.(b)
Classification. Class II.