Radlink Cassette

GUDID 00866389000181

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.

RADLINK, INC.

Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette Digital imaging cassette

• Primary Device ID: 00866389000181
• NIH Device Record Key: bc0dbf40-6e71-4fcb-affd-120ecf321cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radlink Cassette
• Version Model Number: CAS1012
• Company DUNS: 069190036
• Company Name: RADLINK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866389000181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052938

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Radlink Cassette]

• 00866389000198: The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray
• 00866389000181: The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray