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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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CANON INC.
CXDI-70C Wireless
In Commercial Distribution

  • 04960999974965 ()


  • Computed radiography digital imaging scanner
No Description
CANON INC.
CXDI-501C
In Commercial Distribution

  • 04960999814735 ()


  • Computed radiography digital imaging scanner
No Description
CANON INC.
CXDI-501G
In Commercial Distribution

  • 04960999814728 ()


  • Computed radiography digital imaging scanner
No Description
CANON INC.
CXDI-401G COMPACT
In Commercial Distribution

  • 04960999812601 ()


  • Computed radiography digital imaging scanner
No Description
CANON INC.
CXDI-50RF
In Commercial Distribution

  • 04960999810911 ()


  • Computed radiography digital imaging scanner
The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist.
RADLINK, INC.
CR201-1
In Commercial Distribution

  • 00866389000150 ()


  • Computed radiography digital imaging scanner
The Radlink DR Pro system is a digital radiography system with a digital flat panel detector that captures images from any brand of X-ray generator and displays them on a touch screen monitor within four seconds. A local PACS is available to archive and manage images not only from the DR Pro, but also from other DICOM modalities such as X-ray, MRI, CT, and ultrasound.
RADLINK, INC.
DR2200
In Commercial Distribution

  • 00866389000143 ()


  • Computed radiography digital imaging scanner
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.
RADLINK, INC.
C-Arm Kit
In Commercial Distribution

  • 00866389000129 ()


  • Computed radiography digital imaging scanner
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.
RADLINK, INC.
GPS2200
In Commercial Distribution

  • 00866389000105 ()


  • Computed radiography digital imaging scanner
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.
RADLINK, INC.
GPS Trauma
In Commercial Distribution

  • 00864908000162 ()


  • Computed radiography digital imaging scanner
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