← Product Code [IXI](/productcode/IXI) · K970303 # SATURNE MULTILEAF COLLIMATOR (K970303) _General Electric Co. · IXI · Apr 25, 1997 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K970303 ## Device Facts - **Applicant:** General Electric Co. - **Product Code:** [IXI](/productcode/IXI.md) - **Decision Date:** Apr 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5710 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use The Saturne Multileaf collimator is intended to be used for radiation therapy. ## Device Story Multileaf collimator system for GE Saturne charged-particle radiation therapy systems; replaces/augments rectangular field collimators and external beam blockers. Components: collimator assembly, accessory tray, electron applicators, operator console controls, Treatment Preparation Console, and film digitizer. System mounted on rotating gantry; utilizes existing treatment couch for patient positioning. Operator (physician/technician) uses system to define irregular treatment field shapes, improving conformity of radiation dose to target volume. Benefits: eliminates need for external beam blockers in some treatments; enhances precision of radiation delivery. ## Clinical Evidence No clinical data provided; bench testing and operational comparison to predicate devices used to establish equivalence. ## Technological Characteristics Therapy beam collimation system; electromechanical assembly integrated into rotating gantry. Includes collimator control/display, accessory tray, electron applicators, and film digitizer. Operates as an option for GE Saturne charged-particle radiation therapy systems. ## Regulatory Identification A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source. ## Predicate Devices - Varian Associates Multileaf collimators - Philips Medical Systems Multileaf collimators ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K910303 GE Medical Systems General Electric Company PO Box 414, Milwaukee, WI 53201 APR 25 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS January 9, 1997 This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). Contact: Larry A. Kroger, Ph.D. Phone - 414-544-3894 Fax - 414-544-3863 **Identification of Product** The Multileaf Collimator Option is a versatile therapy beam collimation system designed for use on GE Saturne medical charged-particle radiation therapy systems. It is manufactured by GE Medical Systems Europe, 283 Rue de la Miniere, 78530 Buc, France and is distributed by GE Medical Systems, Milwaukee, WI. **Marketed Devices** The current family of Saturne therapy systems uses rectangular field collimators in combination with external beam blockers to contour the treatment field to the desired shape. The Multileaf collimator will permit the use of irregular treatment field shapes to better conform the treatment field to the desired shape without external beam blockers for some treatments. **Device Description** The Multileaf collimator consists of the collimator assembly, a collimator accessory tray and electron applicators, collimator control and display functions on the Saturne operator console, and a Treatment Preparation Console and film digitizer. The accelerator radiation head and Multileaf collimator are assembled in a rotating gantry fastened to a wall. The existing treatment couch is used to support and position the patient. **Indications for Use** The Saturne Multileaf collimator is intended to be used for radiation therapy. **Comparison with Predicate** Saturne Multileaf collimators perform the same function as Multileaf collimators produced by Varian Associates and Philips Medical Systems. Other device characteristics are either the same or comparable for the various collimator systems. **Conclusion** It is the opinion of GE Medical Systems that Saturne Multileaf collimators are substantially equivalent to the named predicate devices based on the similarities in operation and intended use. The Saturne Multileaf collimators are as safe and perform as well as the predicate devices and raise no new questions of safety or effectiveness. 100 Years of Radiology 1895 - 1995 --- **Source:** [https://fda-staging.innolitics.com/device/K970303](https://fda-staging.innolitics.com/device/K970303) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com