mobile C
Cios Fusion - 10308192
Device Description
A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OXO
Device Name: Image-Intensified Fluoroscopic X-Ray System, Mobile
Device Class: 2
Physical State: Hardware
Definition: Fluoroscopy of the human body.
Submission Type ID: 1
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: X-ray transmission through human body
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Human Body
Regulation Number: 892.1650
Third Party Flag: Y
Medical Specialty: RA
Device IdentifiersDevice Id: 04056869009056
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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