← Product Code [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI) · K961902 # SIEMENS BEAM SHAPER (K961902) _Siemens Medical Solutions USA, Inc. · IXI · Aug 8, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K961902 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [IXI](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI.md) - **Decision Date:** Aug 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5710 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Indications for Use The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system. ## Device Story Software utility for radiation therapy planning; inputs leaf positions via digitizer tablet based on x-ray film or paper diagrams; processes leaf, jaw collimator, and gantry position data to generate multileaf collimator (MLC) leaf plans; used in clinical oncology settings by radiation therapy staff; output used to configure MLC for irregular treatment field shaping; enhances precision of radiation delivery to treatment targets. ## Clinical Evidence Bench testing only; performance tests confirmed device consistently performed within design parameters and equivalently to the predicate device. ## Technological Characteristics Software utility; no significant changes in materials, energy source, or performance compared to predicate. Functions as an accessory to the Siemens Digital MEVATRON radiation treatment system. ## 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 - Siemens Multileaf Collimator Hand Control ([K953894](/device/K953894.md)) ## 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} ENS K96190 # SUMMARY OF SAFETY AND EFFECTIVENESS | Submitter's Information: | Dated: May 13, 1996 Siemens Medical Systems Oncology Care Systems Group 4040 Nelson Avenue Concord, CA 94520 | | --- | --- | | Contact Person: | Kenneth R. Michael, Pharm.D. Vice President Regulatory Affairs and Quality Assurance | | Common or Usual Name: | Radiation therapy beam shaping block | | Proprietary Name: | Siemens Multileaf Collimator Beam Shaper | | Classification Names: | Radiation therapy beam shaping block - 21 CFR § 892.5710 Class II, Product Code: RA 90 IXI | | Predicate Device: | Siemens Multileaf Collimator Hand Control K953894 | **Description of Device:** Beam Shaper consists of a digitizer tablet for inputting leaf positions based on field shapes traced from an x-ray film or paper diagram to generate Multileaf Collimator leaf plans. In specifying field geometry, Beam Shaper utilizes leaf, jaw collimator, and gantry position information. **Statement of intended use:** The MLC Beam Shaper software utility provides the ability to create, view, and edit geometric information that will be utilized to form irregular treatment fields through automated changes of multiple leaves that conform to the specified treatment target generate treatment field shapes. The MLC Beam Shaper software is an accessory to the Siemens Multileaf Collimator with Lantis Record and Verify System for the Siemens Digital MEVATRON radiation treatment system. The intended use is the same the predicate device. **Statement of technological characteristics:** The Siemens Multileaf Collimator Beam Shaper software does not have significant change in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it. **Differences:** The minor configuration and specification differences between the Siemens Multileaf Collimator Beam Shaper software and that of the MLC hand control does not alter the intended use or affect the safety and effectiveness of the Siemens Multileaf Collimator Beam Shaper when used as labeled. **Performance Evaluation:** Performance tests were conducted and the results indicated that the device consistently performed within the design parameters and equivalently to the predicate device. ## Medical Systems, Inc. tems 4040 Nelson Avenue Concord, CA 94520 Tel: (510) 246-8200 FAX (510) 246-8284 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K961902](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IXI/K961902) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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