Radlink GPS Tablet 2200

GUDID 00866389000112

The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit.

RADLINK, INC.

Radiology information system

• Primary Device ID: 00866389000112
• NIH Device Record Key: 5a7e67cb-65e1-403b-a87a-c423a8fa6a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radlink GPS Tablet 2200
• Version Model Number: TABLET
• 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	00866389000112 [Primary]

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: 2
• Public Version Date: 2018-03-29
• 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