RADLINK, INC.

Address:815 n nash st,El Segundo,CA,90245,US

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Device Description : The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into a mobile digital radiography system.It is a permanently mounted Tablet PC for image acquisition with built-in PACS and DICOM connectivity. Radlink Pro-Imaging Acquisition and Post-Processing Software are featured on the system as well. It comes with a Cesium wireless flat panel detector.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink Picture Archiving and Communication System (PACS) is an external ser The Radlink Picture Archiving and Communication System (PACS) is an external server for storage and retrieval of varying modality images and their corresponding information.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Device Description : The Radlink GPS Tablet Stand functions as a mobile workstation and charger for t The Radlink GPS Tablet Stand functions as a mobile workstation and charger for the Radlink GPS Tablet and Wireless C-Arm Kit. The stand can be connected to a mains electricity source and charge both the GPS Tablet and WCA Kit simultaneously. Accessories for both devices can also be housed in the GPS Tablet Stand.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The PH GPS Bracket is comprised of Radlink proprietary software and hardware to 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.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charg The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charger for the Radlink GPS Tablet with a secondary monitor. 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.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time f The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS 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 consists of a computer system that uses one ultra-wide monitor.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time f The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS 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 consists of a computer system that uses two monitors . Pre-operative images can be viewed on the top monitor during surgery at the same time that intraoperative images are being viewed on the lower monitor. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which take approximately four seconds to appear on the lower GPS monitor. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the lower monitor of the GPS.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic i 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.

Device Class : 2

Duns Number: 069190036

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Device Description : The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS ( The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is used to wirelessly send images from a video source such as a C-Arm to the Radlink GPS or GPS Tablet. The Radlink Wireless C-Arm Kit is a computer system that accepts video signals from BNC, VGA, or DVI connections and converts these signals into an image file, which is then sent wirelessly to a Radlink GPS or GPS Tablet.

Device Class : 1

Duns Number: 069190036

Premarket Exempt : No

Product Code : LMD

Prescription Use : No

Device Count : 1

Device Description : The Radlink GPS Bucky Cart is a manually operated cart with one compartment that The Radlink GPS Bucky Cart is a manually operated cart with one compartment that is meant for housing and transporting flat panel detectors.

Device Class : 1

Duns Number: 069190036

Premarket Exempt : No

Product Code : HST

Prescription Use : No

Device Count : 1