Product Overview

Luminos Agile Max - 10762472

Device Description

An assembly of devices that comprise a stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time analogue or analogue-to-digital techniques for image capture, display and manipulation 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/injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

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: 04056869009162

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