ADVANCED DIAGNOSTIC VIEWER (ADV)

K963697 · Bio-Vascular, Inc. · LLZ · Nov 27, 1996 · Radiology

Device Facts

• Record ID: K963697
• Device Name: ADVANCED DIAGNOSTIC VIEWER (ADV)
• Applicant: Bio-Vascular, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ADV is intended to create 3D images of the anatomy from a set of CT or MRI images.

Device Story

ADV software processes CT and MR diagnostic images to generate 3D anatomical renderings. Used in clinical settings by healthcare professionals to visualize patient anatomy; output aids in medical diagnosis. Software emphasizes rendering speed and faithfulness to original image data. Device functions as a post-processing tool for diagnostic imaging workflows.

Clinical Evidence

No clinical data submitted. Bench testing performed consistent with software development standards.

Technological Characteristics

Software-based 3D image processing for CT/MR data. Operates as a standalone software package for image rendering.

Indications for Use

Indicated for patients undergoing CT or MRI diagnostic imaging requiring 3D anatomical visualization.

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

• VoxelView® 2.5 (K953259)

Submission Summary (Full Text)

{0}

NOV 27 1996

Appendix K - Class II 510(k) Summary ADV®

K963697

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Predicate Device
VoxelView® 2.5 (K953259).

2. Device Description
ADV is software used for 3D image processing of CT and MR diagnostic images.

3. Intended Use
ADV is intended to create 3D images of the anatomy from a set of CT or MRI images.

4. Comparison with Predicate Device
The products have substantially equivalent features for processing CT/MR imaging data in a three-dimensional format. The ADV software renders a 3D image which exhibits great faithfulness to the original and does so with great speed. Relative to VV2.5, ADV is a more convenient software package to use.

5. Nonclinical Tests
ADV has been developed in a manner consistent with accepted standards for software development, including testing protocols.

6. Clinical Data
Clinical data have not been submitted as part of this premarket notification.

7. Conclusions Drawn from Nonclinical and Clinical Tests
We conclude from these tests that ADV is substantially equivalent to the predicate device in its ability to render accurate 3D images for use in medical diagnosis.

End of Class II 510(k) Summary