Radlink Laser Pro 16

GUDID 00866389000167

The Radlink Laser Pro 16 is a film digitization system that follows a three-step process of acquiring, selecting, and sending digitized films to any desired destination. A laser beam light source and a sealed optic path are used to scan the film that is driven by a clocked, stepping motor. It utilizes a 12-film auto loader, and its software provides image quality control and post-processing functions and enables distribution and routing of DICOM images through a healthcare network.

RADLINK, INC.

Radiography digital imaging scanner

• Primary Device ID: 00866389000167
• NIH Device Record Key: 89642757-ce73-4828-a02d-bc6799f6d3a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radlink Laser Pro 16
• Version Model Number: LP100
• 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	00866389000167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020243

FDA Product Code

• LMA: Digitizer, Image, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-09-21

Devices Manufactured by RADLINK, INC.

• 00864908000131 - Radlink PH GPS Bracket: 2019-07-01 The PH GPS Bracket is comprised of Radlink proprietary software and hardware to duplicate Radlink user interface onto Philips re
• 00864908000148 - Radlink GPS Tablet/Monitor Stand: 2019-07-01 The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charger for the Radlink GPS Tablet with a secondary m
• 00864908000162 - Radlink GPS Trauma: 2019-07-01 The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positi
• 00864908000100 - Radlink DR Tablet Retrofit: 2019-04-23 The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into a mobile digital radiography system.It is a per
• 00864908000124 - Radlink GPS Tablet Stand: 2019-04-23 The Radlink GPS Tablet Stand functions as a mobile workstation and charger for the Radlink GPS Tablet and Wireless C-Arm Kit. Th
• 00866389000105 - Radlink GPS 2200: 2019-04-23 The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positi
• 00866389000129 - Radlink Wireless C-Arm Kit: 2019-04-23 The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is
• 00866389000143 - Radlink DR Pro 2200: 2019-04-23 The Radlink DR Pro system is a digital radiography system with a digital flat panel detector that captures images from any brand