CT-MODELLER SYSTEM

K970617 · Materialise NV · LLZ · Apr 21, 1997 · Radiology

Device Facts

• Record ID: K970617
• Device Name: CT-MODELLER SYSTEM
• Applicant: Materialise NV
• Product Code: LLZ · Radiology
• Decision Date: Apr 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Materialise CT-Modeller System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.

Device Story

Software interface and image segmentation system; processes medical imaging data (CT/MRI) to generate output files for CAD or Rapid Prototyping systems. Operates as a standalone software tool for data conversion and segmentation. Used by clinical or technical personnel to prepare anatomical data for downstream manufacturing or modeling applications. Facilitates transfer of diagnostic imaging information into engineering environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only image segmentation system. Functions as a data interface/converter. Non-sterile.

Indications for Use

Indicated for use as a software interface and image segmentation system to transfer imaging data from medical scanners (CT or MRI) for subsequent use in CAD or Rapid Prototyping systems. No specific patient population, age, or contraindications defined.

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

• SurgiCAD View System (K924630)

Submission Summary (Full Text)

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SUMMARY OF SAFETY AND EFFECTIVENESS
MATERIALISE CT-MODELLER SYSTEM

K970617

## I. GENERAL INFORMATION

Classification Name: System, Image Processing
APR 21 1997

Common Name: Image Processing System
Device Trade Name: Materialise CT-Modeller System
Classification Code: 90LLZ
Submitter's Name & Address: Materialise N.V.
Kapeldreef 60
B-3001 Leuven Belgium
Establishment Registration No: Applied for
Contact Person: Wilfried Vancraen
Summary Preparation Date: February 14, 1997

## II. PREDICATE DEVICE

The CT-Modeller System is claimed to be substantially equivalent in material, design, and function to the SurgiCAD View System cleared by FDA under 510(k) K924630 on April 7, 1993.

## III. Device Description

The Materialise CT-Modeller System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System.

## IV. STERILIZATION

The CT-Modeller System is provided non-sterile.

CT-Modeller System 510(k) - Premarket Notification
Materialise N.V.

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# V. INDICATIONS FOR USE

The Materialise CT-Modeller System is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a Magnetic Resonance imaging scanner or CT scanner. The input data file is processed by the CT-Modeller System and the result is an output data file which may then be used as input data for a CAD or Rapid Prototyping System. The CT-Modeller System which is the subject of this 510(k) premarket notification is confined solely to the software image segmentation system.

# VI. SUBSTANTIAL EQUIVALENCE

The CT-Modeller System is considered to be substantially equivalent to the SurgiCAD View System.

# VII. CONCLUSION

The CT-Modeller System is considered to be substantially equivalent in design, material and function to the SurgiCAD View System and is believed to perform as well as the SurgiCAD System.

CT-Modeller System 510(k) - Premarket Notification
Materialise N.V.
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