IMAGEFUSION

K960071 · Radionics Software Applications, Inc. · LLZ · Apr 17, 1996 · Radiology

Device Facts

• Record ID: K960071
• Device Name: IMAGEFUSION
• Applicant: Radionics Software Applications, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Image processing and comparing an MR and a CT image set or two different CT image sets.

Device Story

ImageFusion system; image processing workstation; inputs MR and CT image sets; transforms non-stereotactic MR images into reference CT stereotactic image space; eliminates need for localizing hardware; used by clinicians for treatment planning in stereotactic neurosurgery, radiosurgery, and radiotherapy; output fused images for visualization and comparison; facilitates clinical decision-making by integrating multi-modal imaging data; improves patient outcomes by enabling precise stereotactic localization without additional hardware.

Clinical Evidence

Bench testing only. System testing verified registration accuracy of MR images in stereotactic CT space (1.5 ± 0.6 mm average; 2.5 mm maximum for individual landmarks). Verification of bone segmentation and landmark alignment accuracy performed.

Technological Characteristics

Image processing workstation; software-based image fusion; bone segmentation and landmark alignment algorithms; non-stereotactic to stereotactic image space transformation; standalone workstation architecture.

Indications for Use

Indicated for patients undergoing stereotactic neurosurgery, radiosurgery, or radiotherapy requiring the fusion of MR and CT image sets or multiple CT image sets for treatment planning.

Regulatory Classification

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).

Predicate Devices

• RSA StereoPlan (K960071)

Submission Summary (Full Text)

{0}

ImageFusion
Summary of Safety and Effectiveness

# Summary of Safety and Effectiveness

## General Information

K960071
K960071

| Classification: | Class II |
| --- | --- |
| Common Name | Image Correlation System |
| Device Trade Name: | ImageFusion |
| Intended Uses | Image processing and comparing an MR and a CT image set or two different CT image sets. |
| Predicate Device: | RSA StereoPlan |
| Establishment Name and Address: | Radionics Software Applications, Inc.
22 Terry Avenue
Burlington, MA 01803 |
| Contact Name and Phone: | Amy J. LaForte, Ph.D.
[phone] |
| Establishment Registration Number: | 1222895 |
| Performance Standard | None established under Section 514 |

APR 17 1996

## Substantial Equivalence Determination

A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.

## Safety Summary

RSA ImageFusion system testing verifies that the registration of MR images in stereotactic CT space is accurate and is approximately $1.5 \pm 0.6 \mathrm{~mm}$ on average and $2.5 \mathrm{~mm}$ maximum for individual landmarks. Further, system and unit testing verify that features such as bone segmentation and landmark alignment, which form the basis of a fusion session, are accurate.

## General Safety and Effectiveness Concerns

The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and installation sessions provide assurance that the user understands all aspects of the ImageFusion System and its intended functionality. This information promotes safe and effective use of the device.

## Description of the Device and Basis for Substantial Equivalence

The ImageFusion system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available StereoPlan system. Like StereoPlan, the ImageFusion system includes an image processing work station used to evaluate, manipulate, and compare MR and CT image data. In addition, ImageFusion software can reconstruct (fuse) non-stereotactic MR images into the image space of a reference CT stereotactic image set for subsequent stereotactic use, eliminating the need for the localizing hardware required in StereoPlan to define stereotactic locations in MR images. Subsequently, fused images can be used in the treatment planning for stereotactic neurosurgery, radiosurgery and radiotherapy procedures in the same way that supplementary stereotactic MR or CT images are utilized in StereoPlan.

January 4, 1996
Page 94