ADVANTAGE WINDOWS WITH FUNCTOOL OPTION

K960265 · GE Medical Systems · LLZ · Jul 3, 1996 · Radiology

Device Facts

• Record ID: K960265
• Device Name: ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
• Applicant: GE Medical Systems
• Product Code: LLZ · Radiology
• Decision Date: Jul 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

Device Story

Software module for Advantage Windows workstation; processes dynamic CT and MR temporal datasets (single or multi-slice, equally spaced time intervals). Transforms temporal image data into Time Intensity Curves and parametric images. Used in clinical settings by radiologists/technicians for post-processing. Output assists clinicians in visualizing temporal variations, aiding diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based functional imaging package; operates on GE CT/MR workstation platforms; processes temporal image datasets; generates parametric maps and time-intensity curves.

Indications for Use

Indicated for use by clinicians to provide supplemental information from CT and MR temporal datasets for diagnostic purposes.

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

• Advantage Windows Diagnostic Workstation (K913770)
• Signa MR Systems (K913475)

Submission Summary (Full Text)

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K96 0265
JUL - 3 1996
GE Medical Systems
P.O. Box 414, W-709
Milwaukee, WI 53201
USA

# SUMMARY OF INFORMATION RESPECTING SAFETY AND EFFECTIVENESS

January 12, 1996

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Contact: Larry A. Kroger, Ph.D.
Phone: [phone]
Fax: [phone]

Product: Advantage Windows with FuncTool Option
CT/MR Accessory
Manufactured by GE Medical Systems - Europe, Buc, France
Distributed by GE Medical Systems, Milwaukee, WI

1) Indications for Use

The FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

2) Device Description

FuncTool is a functional Imaging software package which allows to display the temporal variation in dynamic CT and MR datasets. Single or multi-slice datasets, with equally spaced time intervals are used for input. The purpose is to provide Time Intensity Curves and parametric images that provide clinical information for diagnosis purposes. This software is used during post-processing of MR and CT images on GE's CT and MR Systems.

3) Marketing History

This software is presently being marketed as the Multiple Region of Interest (MIROI) function in the Signa MR Systems 510(k) K913475. FuncTool automates what is presently done manually.

4) Comparison with Predicate

The use of the FuncTool Option does not result in any additional potential hazards when compared to previously marketed devices.

5) Conclusions

It is the opinion of GE that the FuncTool Option is substantially equivalent to the Advantage Windows Diagnostic Workstation (K913770) and Signa Advantage (K913475). The FuncTool Option does not include any new indications for use, nor does use of this device result in any new potential hazards.