Radlink PH GPS Bracket

GUDID 00864908000131

The PH GPS Bracket is comprised of Radlink proprietary software and hardware to duplicate Radlink user interface onto Philips reference monitor of the MVS utilizing a switch box that shifts the video signal between Philips and Radlink on the reference monitor. Not only does Radlink solution expand the field of view of Philips C-Arms utilizing Pano function, but it also facilitates intra-operative image analysis by assisting surgeons to evaluate acetabular cup position, limb length discrepancy, and femoral offset during Total Hip Arthroplasty. The PH GPS Bracket comes with software features such as image stitching and Surgeon’s Checklist™ software that provides surgeons with real-time feedback on orthopedic implant component positioning. Pre-operative images can be viewed on the device during surgery, which surgeons can use to reference against the intra-operative images captured during the procedure.

RADLINK, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 00864908000131
• NIH Device Record Key: 4029e095-e07d-4ab3-bc61-e2461d63af38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radlink PH GPS Bracket
• Version Model Number: PH BRACKET
• 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	00864908000131 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-01
• Device Publish Date: 2019-06-21

Devices Manufactured by RADLINK, INC.

• 00864908000131 - Radlink PH GPS Bracket: 2019-07-01The PH GPS Bracket is comprised of Radlink proprietary software and hardware to duplicate Radlink user interface onto Philips reference monitor of the MVS utilizing a switch box that shifts the video signal between Philips and Radlink on the reference monitor. Not only does Radlink solution expand the field of view of Philips C-Arms utilizing Pano function, but it also facilitates intra-operative image analysis by assisting surgeons to evaluate acetabular cup position, limb length discrepancy, and femoral offset during Total Hip Arthroplasty. The PH GPS Bracket comes with software features such as image stitching and Surgeon’s Checklist™ software that provides surgeons with real-time feedback on orthopedic implant component positioning. Pre-operative images can be viewed on the device during surgery, which surgeons can use to reference against the intra-operative images captured during the procedure.
• 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