Mobile, diagnostic X-ray imaging and viewing system. Used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures.

Mobile, diagnostic X
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A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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. Images can be both real-time and delayed formats.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OWB

Device Name: Interventional Fluoroscopic X-Ray System

Device Class: 2

Physical State: Fluoroscopic X-Ray system

Definition: Interventional fluoroscopy

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluoroscopy

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

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

Code: JAA

Device Name: System, X-Ray, Fluoroscopic, Image-Intensified

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00884838055490

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