Radlink Wireless C-Arm Kit

Basic Information

• Brand Name: Radlink Wireless C-Arm Kit
• Primary DI: 00866389000129
• Version / Model: C-Arm Kit
• Company Name: RADLINK, INC.
• Labeler DUNS: 069190036
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2019-04-23
• Public Version Status: Update
• Public Device Record Key: 072ef831-daff-49ca-a4b9-977d733e4439

Device Description

The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is used to wirelessly send images from a video source such as a C-Arm to the Radlink GPS or GPS Tablet. The Radlink Wireless C-Arm Kit is a computer system that accepts video signals from BNC, VGA, or DVI connections and converts these signals into an image file, which is then sent wirelessly to a Radlink GPS or GPS Tablet.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMD	System, Digital Image Communications, Radiological	Radiology	892.2020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17904	Computed radiography digital imaging scanner	A device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866389000129	GS1