Optima IGS 320 001 UDI
Optima - IGS 320 001
Device Description
A stationary diagnostic fluoroscopic x-ray system specifically designed to optimize the capability of users to visually and quantitatively evaluate the anatomy and function of blood vessels of the heart, brain and other organs, as well as the lymphatic system. It uses digital techniques for real-time image capture, display and manipulation and typically includes spot-film capabilities in addition to the fluoroscopic features. It is commonly used in conjunction with an injected x-ray contrast medium during either imaging or x-ray guided surgical or interventional procedures. Images can be viewed in both real-time and delayed formats.
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: 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: 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
Code: IZI
Device Name: System, X-Ray, Angiographic
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: 892.1600
Third Party Flag: N
Medical Specialty: RA
Device IdentifiersDevice Id: 00840682117975
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