SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

K963952 · Ge Dec Medical Systems · OWB · Dec 23, 1996 · Radiology

Device Facts

• Record ID: K963952
• Device Name: SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
• Applicant: Ge Dec Medical Systems
• Product Code: OWB · Radiology
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Series 9600 Mobile Digital Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.

Device Story

Mobile C-arm fluoroscopic imaging system; consists of C-arm unit (x-ray generator, tube, image intensifier) and mobile workstation (monitors, image processing, storage). Used in hospitals and clinics by physicians, surgeons, cardiologists, radiologists, and technologists. Performs linear/rotational motions for patient positioning. Captures x-ray inputs; processes and displays images for real-time visualization during procedures. Supports peripheral interfaces (printers, VCRs). Facilitates diagnostic, surgical, and interventional guidance; aids clinical decision-making via immediate visual feedback.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with 21 CFR 1020.30-32 and international safety standards (IEC 601 series, UL 187, CSA-C22.2) serves as evidence of safety and effectiveness.

Technological Characteristics

Mobile C-arm diagnostic x-ray system. Components: high-voltage generator, x-ray tube, image intensifier. Connectivity: RS-170/CCIR video, DICOM 3.0. Standards: 21 CFR 1020.30-32, ANSI/NFPA 99, ANSI/NFPA 70, UL 187, CSA-C22.2 No.601.1-M90, IEC 601-1, IEC 601-1-2, IEC 601-1-3, IEC 601-2-7, 93/42/EEC.

Indications for Use

Indicated for fluoroscopic and spot-film imaging of patients during diagnostic, surgical, and interventional procedures, including cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room applications. No specific age or gender contraindications stated.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• OEC Medical Systems - Series 9600 Mobile Digital Imaging System (original 510(k) device)
• Philips Medical Systems - BV 29 Mobile Imaging System
• Philips Medical Systems - BV 212 Mobile Imaging System

Submission Summary (Full Text)

{0}

OEC
OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY, UTAH 84116
801-328-9300
FAX [phone]
K963952
P1n/3
DEC 23 1996

# 510(k) SUMMARY

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.

## Date:

September 27, 1996

## Name of Submitter:

OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City, UT 84116
801-328-9300

## Corresponding Official:

Ted L. Parrot,
Vice President, Quality/Regulatory Affairs.

## Device Proprietary Name:

Series 9600 Mobile Digital Imaging System (modified - Phase III)

## Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified

## Common/Usual Names:

Fluoroscopic Imaging System
Mobile C-arm

Page 1-SUM

{1}

September 1996
510(k) Summary
Modified Series 9600 Mobile Digital Imaging System
K963952
P293

## Substantial Equivalence:

The modified Series 9600 Mobile Digital Imaging System is substantially equivalent to the following systems which are currently marketed:

- OEC Medical Systems - Series 9600 Mobile Digital Imaging System [original 510(k) device]
- Philips Medical Systems - BV 29 Mobile Imaging System
- Philips Medical Systems - BV 212 Mobile Imaging System

All of these devices are mobile C-arm type diagnostic x-ray systems intended for fluoroscopic imaging. The systems all include a high-voltage x-ray generator, x-ray tube, image intensifier, video image displays, digital image processing and image storage capability.

## Device Description:

### Indications For Use

The Series 9600 Mobile Digital Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include, but are not limited to, cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.

### User Characteristics

The device is used by health care professionals such as physicians, surgeons, cardiologists, radiologists and technologists. The device is used in hospitals, out-patient clinics and other clinical environments to provide fluoroscopic and spot-film imaging during diagnostic, surgical and interventional procedures. It is expected that the device will be used on a daily basis. Users are trained by OEC applications specialists and/or qualified site personnel in the proper use of the device. The device labeling stipulates that only properly trained persons operate this equipment.

### General Description

The Series 9600 system is comprised of two mobile units: the C-arm unit supports the high-voltage generator, x-ray components and x-ray controls; and the other unit, a mobile workstation, supports image display monitors, image processing and recording devices. The C-arm includes a “C” shaped arm that supports an x-ray tube on one end and an image intensifier on the other. The C-arm is designed to perform linear and rotational motions which allow the user to position the x-ray imaging components at various angles and distances with respect to the patient.

Interfaces are provided for optional peripheral devices such as thermal or laser printers and VCRs. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DICOM 3.0.

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{2}

September 1996
510(k) Summary
Modified Series 9600 Mobile Digital Imaging System
K963952
p 3073

# Standards:

In addition to complying with the Federal Performance Standard for Diagnostic X-ray Systems (21 CFR §1020.30-32), the modified Series 9600 Mobile Digital Imaging System is designed in accordance with guidelines established in the following standards:

- ANSI/NFPA 99, Standard for Health Care Facilities
- ANSI/NFPA 70, National Electrical Code
- UL 187, Standard for X-ray Equipment
- CSA-C22.2 No.601.1-M90, Medical Electrical Equipment
- IEC 601-1, Medical Electrical Equipment, General Requirements for Safety
- IEC 601-1-2, Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility
- IEC 601-1-3, Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment
- IEC 601-2-7, Medical Electrical Equipment, Safety of HV/X-ray Generators
- 93/42/EEC - Annex 1, Essential Requirements of the Medical Devices Directive

This concludes this 510(k) Summary.


Ted L. Parrot,
Vice President, Quality Assurance/Regulatory Affairs
OEC Medical Systems, Inc.

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