PHILIPS EASYVISION

K963980 · Philips Medical Systems North America, Inc. · LLZ · Dec 23, 1996 · Radiology

Device Facts

• Record ID: K963980
• Device Name: PHILIPS EASYVISION
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The optional package SPINE for use in PHILIPS EasyVision X-Ray workstations.

Device Story

Optional software package for Philips EasyVision X-Ray workstations; processes X-ray imaging data; provides visualization tools for spine imaging; used in clinical settings by radiology staff; assists clinicians in diagnostic review of spine images; enhances image interpretation for clinical decision-making.

Clinical Evidence

No clinical data provided; safety and effectiveness supported by past experience with substantially equivalent devices.

Technological Characteristics

Software package for EasyVision X-Ray workstation; provides image processing and visualization functionality.

Indications for Use

Indicated for use in Philips EasyVision X-Ray workstations for the processing and visualization of spine-related X-ray imaging data.

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).

Submission Summary (Full Text)

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PHILIPS

# Philips Medical Systems

P.O. Box 10000, 5680 DA Best. The Netherlands

Department of Health and Human Services
Center for Devices and Radiological Health
Office of Device Evaluation
Pre-Market Notification section.

K963980
DEC 23 1996

QA Department XRD Best
XBQ87-960792/HD/wp

1996.05.20

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

for the optional package:

### SPINE

for use in PHILIPS EasyVision X-Ray workstations

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

The undersigned certifies that the 510(k) Pre-Market notification for the above referenced products contains adequate information and data to enable CDRH to determine substantial equivalence.

This information and data is summarized as follows:

1. The information for Users contains comprehensive information to insure safe and effective use;

2. Past experience with substantially equivalent predicate devices/methods has shown our device to be safe and effective when used as directed in the Information for Users.

R.W. Rijntjes
Approbation Officer
Quality Assurance dept. XSB / XCB
Philips Medical Systems, Best
The Netherlands.

Philips Medical Systems Nederland B.V.
Veenpluis 6, Best. The Netherlands
Tel: [phone]
Fax: [phone]
Commercial Register Eindhoven no. 17060498