← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K970623

# IMMERGE IMAGE CORRELATION (K970623)

_Surgical Navigation Technologies, Inc. · LLZ · Apr 28, 1997 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970623

## Device Facts

- **Applicant:** Surgical Navigation Technologies, Inc.
- **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md)
- **Decision Date:** Apr 28, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Software as a Medical Device

## Intended Use

This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

## Device Story

Software system; performs spatial registration of two image sets; enhances imaging information for physician review. Used in clinical settings for diagnosis and treatment planning; supports image-guided surgery, stereotactic radiosurgery, and radiotherapy. Physician operates system to correlate images; output used to inform surgical or therapeutic planning. Benefits include improved visualization and spatial accuracy for clinical decision-making.

## Technological Characteristics

Software-based image correlation system; performs spatial registration of image data sets.

## Regulatory Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

## Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

## Submission Summary (Full Text)

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K970623

# APR 28 1997

## Summary of Safety and Effectiveness

### ImMerge™ Image Correlation System

I. **Company:** Surgical Navigation Technologies
530 Compton St.
Broomfield, CO 80020
(303) 439-9709

II. **Product Name:** ImMerge™ Image Correlation System

III. This submission describes a software system that provides precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

IV. The ImMerge™ Image Correlation System was shown to be substantially equivalent to other commercially available image correlation systems. Evidence of the substantial equivalence was provided.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970623](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K970623)

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