Radlink Cassette

Basic Information

• Brand Name: Radlink Cassette
• Primary DI: 00866389000181
• Version / Model: CAS1012
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bc0dbf40-6e71-4fcb-affd-120ecf321cfa

Device Description

The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation.This model is designed for 10"x12" plates.

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
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	892.1680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44823	Digital imaging cassette	A device used in medical imaging applications to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system and a computed radiography scanner, in the process of producing a digital image of a patient radiation pattern.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866389000181	GS1

Premarket Submissions

Submission Number	Supplement Number
K052938	000