EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS

K962010 · Philips Medical Systems (Cleveland), Inc. · LLZ · Mar 21, 1997 · Radiology

Device Facts

• Record ID: K962010
• Device Name: EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.

Device Story

Option for CT X-ray systems; processes X-ray transmission data from multiple axial angles; performs computer reconstruction to generate cross-sectional body images. Used in clinical settings by trained healthcare professionals; integrates with existing CT system signal analysis and display equipment. Output provides diagnostic images for clinical review; assists in anatomical visualization and diagnostic decision-making. Benefits include enhanced imaging capabilities for CT examinations.

Clinical Evidence

Bench testing only. Effectiveness established through internal evaluation during development phases; product performs in accordance with development specifications. No clinical trial data provided.

Technological Characteristics

Component for CT X-ray systems; complies with Federal Diagnostic X-ray Performance Standards (21 CFR 1020.30-31) and UL 187 safety standards. Includes signal analysis and display equipment. Operates via computer reconstruction of X-ray transmission data.

Indications for Use

Indicated for use in computed tomography (CT) imaging for the production of cross-sectional body images. Intended for use by trained healthcare professionals in certified CT systems.

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 3D Navigator Option (K954355)

Submission Summary (Full Text)

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MAR 21 1997
K962010

# Picker 510(k) Notice

## epi-Scope Option

## Summary of Safety and Effectiveness

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (DRAERD) of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3) for the epi-Scope Option.

The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.

Functional specifications and operator’s instructions (preliminary) are included in the attachments. Final documentation will be provided with production units.

The epi-Scope Option is substantially equivalent to legally marketed device. The epi-Scope Option is under control of health care professionals who are trained and responsible for computed tomography examinations. The epi-Scope Option will be used in certified CT Systems that comply with Federal Diagnostic X-ray Performance Standards.

Picker adheres to FDA GMPs, 21 CFR 1020.30-31, voluntary standards for safety/effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation).

Effectiveness is established by Picker’s evaluation throughout all phases of the epi-Scope Option development. The product will perform in accordance with the development specifications. The epi-Scope Option represents the current state-of- the-art technology, therefore, is equivalent to legally marketed Advantage 3D Navigator Option manufactured by General Electric in Document Control No. K954355.

Picker has reviewed all known information and performed an investigation as to the causes of safety/effectiveness concerning the epi-Scope Option. In addition, all information contained in this 510(k) Notice is accurate and complete.

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