LINAC SCALPEL FLOORSTAND

K964517 · Surgical Navigation Technologies, Inc. · IYE · Apr 1, 1997 · Radiology

Device Facts

• Record ID: K964517
• Device Name: LINAC SCALPEL FLOORSTAND
• Applicant: Surgical Navigation Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Apr 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for patients undergoing stereotactic radiosurgery or radiotherapy procedures requiring precise patient positioning and secondary collimation at the isocenter of a linear accelerator.

Regulatory Classification

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)

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K964517
APR - 1 1997

# Summary of Safety and Effectiveness

## Linac Scalpel™ Floorstand System

### I. Company:

Surgical Navigation Technologies
530 Compton St.
Broomfield, CO 80020
[phone]

### 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.