Radlink Cassette

GUDID 00866389000198

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 14"x17" plates.

RADLINK, INC.

Digital imaging cassette

• Primary Device ID: 00866389000198
• NIH Device Record Key: 2a26d11d-66b1-46e8-b109-40b19e5bbd67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radlink Cassette
• Version Model Number: CAS1417
• 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	00866389000198 [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