(82 days)
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.
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 Carm 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.
This document is a 510(k) summary for the OEC Medical Systems Series 9600 Mobile Digital Imaging System (modified - Phase III). It focuses on establishing substantial equivalence with existing devices rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, the provided text does not contain the information required to populate the table and answer the questions about acceptance criteria and a study proving the device meets those criteria.
The document details:
- The device's proprietary and classification names.
- Indications for use and user characteristics.
- A general description of the system.
- The standards the device complies with (e.g., FDA Federal Performance Standard for Diagnostic X-ray Systems, ANSI/NFPA, UL, CSA, IEC standards related to electrical safety and radiation protection).
However, it does not include:
- A set of quantitative acceptance criteria for image quality, diagnostic accuracy, or any other performance metric.
- A study design, methodology, or results demonstrating the device's performance against such criteria.
- Information about training/test set sample sizes, data provenance, ground truth establishment, expert qualifications, or MRMC studies.
The purpose of this 510(k) summary is to demonstrate that the modified Series 9600 is substantially equivalent to legally marketed predicate devices, not to prove its performance against novel acceptance criteria through a specific clinical or technical study.
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Image /page/0/Picture/0 description: The image shows the logo for OEC Medical Systems, Inc. The logo consists of three large, bold letters: "O", "E", and "C". The "E" is stylized with three horizontal lines instead of a single bar. Below the letters, the words "OEC MEDICAL SYSTEMS, INC" are printed in a smaller, sans-serif font.
384 WRIGHT BROTHERS DRIVE
DEC 23 1996
1963952
Pinja
SALT LAKE CITY. UTAH 84116
801-328-9300 FAX 801-328-4300
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
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Substantial Equivalence:
963952
P293
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 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 Carm 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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510(k) Summarv Modified Series 9600 Mobile Digital Imaging System
14963952 13073
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. Panos
Ted L. Parrot. Vice President, Quality Assurance/Regulatory Affairs OEC Medical Systems, Inc.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.