| Primary Device ID | 00864908000117 |
| NIH Device Record Key | ed193300-2b35-4a66-8bba-b7121c5477a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radlink PACS |
| Version Model Number | PACS-SW |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00864908000117 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-01-24 |
| 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 |