Interventional Fluoroscopy
Multitom Rax - 10860700
Device Description
A stationary 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. Images can be viewed in both real-time and delayed format.
Environmental Conditions
- 106000.00
- 70000.00
- 75.00
- 20.00
- 35.00
- 15.00
- 106000.00
- 50000.00
- 95.00
- 10.00
- 70.00
- 20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: JAK
Device Name: System, X-Ray, Tomography, Computed
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: 892.1750
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 IdentifiersDevice Id: 04056869009179
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