← Product Code [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE) · K964517 # LINAC SCALPEL FLOORSTAND (K964517) _Surgical Navigation Technologies, Inc. · IYE · Apr 1, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964517 ## Device Facts - **Applicant:** Surgical Navigation Technologies, Inc. - **Product Code:** [IYE](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE.md) - **Decision Date:** Apr 1, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.5050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for Use This submission describes a floorstand based coordinate and fixation system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Linac Scalpel™ Floorstand is designed to provide secondary collimation and a fixed isocenter for Radiosurgery or Radiotherapy when used in conjunction with a commercially available Linear Accelerator. ## Device Story Mechanical floorstand system; provides secondary collimation and fixed isocenter for linear accelerator-based stereotactic radiosurgery/radiotherapy. System attaches via gimbal bearing to linear accelerator head; positioned at predetermined floor points. Controls collimation accuracy during radiation beam arcing and patient position accuracy during couch repositioning. Used in clinical radiation oncology settings by trained medical staff. Ensures precise alignment of radiation beam to target; facilitates accurate dose delivery; improves treatment precision for patient. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical structure; gimbal bearing attachment; floor-mounted coordinate and fixation system. No electronic, software, or energy-based components described. ## Regulatory Identification A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories. ## 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} K964517 APR - 1 1997 # Summary of Safety and Effectiveness ## Linac Scalpel™ Floorstand System ### I. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709 ### II. Product Name: Linac Scalpel™ Floorstand System ### III. This submission describes a floorstand based coordinate and fixation system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. The Linac Scalpel™ Floorstand is designed to provide secondary collimation and a fixed isocenter for Radiosurgery or Radiotherapy when used in conjunction with a commercially available Linear Accelerator. The Linac Scalpel™ Floorstand consists of a mechanical structure which is located on the floor at predetermined points and attaches via a gimbal bearing to the head of a linear accelerator. The floorstand is designed to precisely control the accuracy of the collimation during the arcing of the radiation beam from the linear accelerator and the accuracy of the patient position during couch repositioning between arcs. ### IV. The Linac Scalpel™ Floorstand System was shown to be substantially equivalent to other commercially available patient positioning systems for use in conjunction with linear accelerator-based stereotactic radiosurgery/radiotherapy treatments. --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964517](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/IYE/K964517) **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. 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