(63 days)
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, 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 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 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.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. The document describes the device, its intended use, and substantial equivalence to other marketed devices. It also lists the standards the device complies with. There is no performance data, clinical study information, or details about ground truth establishment.
Therefore, I cannot provide the requested information based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for OEC Medical Systems, Inc. The logo consists of the letters "OEC" stacked on top of the words "OEC MEDICAL SYSTEMS, INC". The letters "OEC" are in a bold, sans-serif font, and the words "OEC MEDICAL SYSTEMS, INC" are in a smaller, serif font. The logo is black and white.
384 WRIGHT brothers drive
MAR 1 1 1997
SALT LAKE CITY. UTAH 84116
801-328-9300 FAX 801-328-4300 K970063
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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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, 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 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 U.S. domestic markets, CCIR format for international markets, and DICOM 3.0.
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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
Fhis concludes this 510(k) Summary.
Ains
Ted L. Parrot, Vice President, Quality Assurance/Regulatory Affairs OEC Medical Systems, Inc.
TLP/jw
§ 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.