SERIES 7600 MOBILE DIGITAL C-ARM

K970063 · Ge Dec Medical Systems · OWB · Mar 11, 1997 · Radiology

Device Facts

• Record ID: K970063
• Device Name: SERIES 7600 MOBILE DIGITAL C-ARM
• Applicant: Ge Dec Medical Systems
• Product Code: OWB · Radiology
• Decision Date: Mar 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Series 7600 Mobile Digital C-arm 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 digital C-arm system for fluoroscopic and spot-film imaging. Comprised of two units: C-arm unit (x-ray tube, image intensifier, high-voltage generator) and mobile workstation (monitors, image processing, recording). Performs linear/rotational motions for patient positioning. Used in hospitals, clinics, and ORs by physicians, surgeons, cardiologists, radiologists, and technologists. Inputs: x-ray radiation; Outputs: real-time fluoroscopic video and spot-film images. Supports peripheral interfaces (printers, VCRs) and DICOM 3.0/RS-170/CCIR video standards. Assists clinicians in visualizing anatomy during procedures to guide surgical/interventional decision-making.

Clinical Evidence

No clinical data provided; bench testing only. Compliance with Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30-32) and international safety/EMC standards (UL 2601-1, CSA-C22.2 No.601.1-M90, IEC 601 series) cited as evidence of safety and effectiveness.

Technological Characteristics

Mobile C-arm fluoroscopic imaging system. Components: high-voltage generator, x-ray tube, image intensifier, workstation with monitors. Connectivity: DICOM 3.0, RS-170, CCIR. Standards: 21 CFR 1020.30-32, UL 2601-1, CSA-C22.2 No.601.1-M90, IEC 601-1, IEC 601-1-2, IEC 601-1-3, IEC 601-2-7, IEC 601-2-32.

Indications for Use

Indicated for fluoroscopic and spot-film imaging during diagnostic, surgical, and interventional procedures across various clinical specialties including cholangiography, urology, orthopedics, neurology, vascular, cardiac, critical care, and emergency medicine. 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 - Compact 7600
• Philips Medical Systems - BV 25 Gold
• Siemens Medical Systems - Siremobil Compact

Submission Summary (Full Text)

{0}

OEC

OEC MEDICAL SYSTEMS, INC

384 WRIGHT BROTHERS DRIVE

SALT LAKE CITY, UTAH 84116

801-328-9300

FAX [phone]

MAR 11 1997

K970663

# 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:

December 31, 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 7600 Mobile Digital C-arm

## Classification Name:

System, X-ray, Fluoroscopic, Image-Intensified

## Common/Usual Names:

Fluoroscopic Imaging System
Mobile C-arm

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December 1996
510(k) Summary
Series 7600 Mobile Digital C-arm

## Substantial Equivalence:

The Series 7600 Mobile Digital C-arm is substantially equivalent to the following systems which are currently marketed:

- OEC Medical Systems - Compact 7600
- Philips Medical Systems - BV 25 Gold
- Siemens Medical Systems - Siremobil Compact

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 7600 Mobile Digital C-arm 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 7600 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 U.S. domestic markets, CCIR format for international markets, and DICOM 3.0.

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December 1996
510(k) Summary
Series 7600 Mobile Digital C-arm

## Standards:

In addition to complying with the Federal Performance Standard for Diagnostic X-ray Systems (21 CFR §1020.30-32), the Series 7600 Mobile Digital C-arm is designed in accordance with product safety requirements established in the following standards:

- UL 2601-1, Medical Electrical 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
- IEC 601-2-32, Medical Electrical Equipment, Safety of Associated X-ray Equipment

This concludes this 510(k) Summary.


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

TLP/jw

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