← Product Code [IYE](/productcode/IYE) · K962792

# LINAC SCALPEL TREATMENT PLANNING SYSTEM (K962792)

_Surgical Navigation Technologies, Inc. · IYE · Nov 12, 1996 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K962792

## Device Facts

- **Applicant:** Surgical Navigation Technologies, Inc.
- **Product Code:** [IYE](/productcode/IYE.md)
- **Decision Date:** Nov 12, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.5050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Therapeutic

## Indications for Use

The LINAC Scalpel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small cranial lesions such as arteriovenous malformations, pituitary tumors, pinealomas, acoustic neuromas and malignant neoplasms.

## Device Story

LINAC Scalpel Treatment Planning System; radiation treatment planning software; hardware includes high-resolution UNIX graphics computer, printer, digitizing graphics tablet. Used by clinicians to plan radiation therapy for small cranial lesions. System processes input data to assist in precise treatment planning; output used by healthcare providers to guide radiation delivery. Benefits include increased speed and precision in planning cranial lesion treatments.

## Technological Characteristics

System components: high-resolution UNIX graphics computer, printer, digitizing graphics tablet. Software-based radiation treatment planning application.

## 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.

## Predicate Devices

- Commercially available Radiation Treatment Planning Systems

## Submission Summary (Full Text)

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F 510(k) Summary

NOV 12 1996
K962792

F.1 Company

Surgical Navigation Technologies, Inc. 530 Compton Bloomfield, CO 80020 USA

F.2 Product Name

LINAC Scalpel Treatment Planning System

F.3 Description

The LINAC Scalpel Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing graphics tablet, and radiation treatment planning application software.

F.4 Intended Use and Indications

The LINAC Scalpel Treatment Planning System is intended as a aid in quickly and precisely planning the radiation treatment of small cranial lesions such as arteriovenous malformations, pituitary tumors, pinealomas, acoustic neuromas and malignant neoplasms.

F.5 Substantial Equivalence

The LINAC Scalpel Treatment Planning System was claimed to be substantially equivalent to commercially available Radiation Treatment Planning Systems. Information pertaining to these systems was provided in the submission.

RS-A-00-002
SNT Proprietary
F-1

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**Source:** [https://fda-staging.innolitics.com/device/K962792](https://fda-staging.innolitics.com/device/K962792)

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