Genesis Urology Imaging System, Left, FPD, 65 KW, 480 V

Product Overview

Genesis Urology Imaging System, Left, FPD, 65 KW, 480 V
Dornier MedTech - Genesis

Device Description

A stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis capabilities.

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: 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 Identifiers

Device Id: 04049957004231

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

Educational Resources