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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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DR-ID900CL - 04547410316872

The DR-ID 900CL is a workstation intended to associate digital (for CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
FUJIFILM CORPORATION
DR-ID900CL
In Commercial Distribution

  • 04547410316872 ()


  • Stationary basic diagnostic x-ray system, digital

FCR PRIMA T2 - 04547410239829

The FCR PRIMA T2 (CR-IR 392) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 392
In Commercial Distribution

  • 04547410239829 ()


  • Computed radiography digital imaging scanner

FDR D-EVO G43s - 04547410235975

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A E
In Commercial Distribution

  • 04547410235975 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35i - 04547410235944

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A E
In Commercial Distribution

  • 04547410235944 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24s - 04547410225587

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE WIRED E
In Commercial Distribution

  • 04547410225587 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24i - 04547410225570

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE E
In Commercial Distribution

  • 04547410225570 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FUJI IP CASSETTE CC - 04547410211252

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 35.4X35.4cm(14X14)
In Commercial Distribution

  • 14547410211259 ()
  • 04547410211252 ()

  • 35.4X35.4 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410211245

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 35.4X43.0cm(14X17)
In Commercial Distribution

  • 14547410211242 ()
  • 04547410211245 ()

  • 35.4X43.0 CM


  • Computed radiography digital imaging scanner

FDR D-EVO plus C35i - 04547410196863

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE E
In Commercial Distribution

  • 04547410196863 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

FCR PRIMA II - 04547410189988

The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 391RU
In Commercial Distribution

  • 04547410189988 ()


  • Computed radiography digital imaging scanner

Cradle - 04547410180282

The Cradle is used for storing the fl at panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle can be charged. In addition, when the Cradle is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR600 STAND E
In Commercial Distribution

  • 04547410180282 ()


  • Stationary basic diagnostic x-ray system, digital

Li-ion Battery charger - 04547410180220

A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital

Li-ion Battery - 04547410180213

A battery pack for the flat panel sensor (DR-ID 601SE, DR-ID 602SE and DR-ID 611SE) used in wireless communication mode.
FUJIFILM CORPORATION
DR601 SE BATTERY E
In Commercial Distribution

  • 04547410180213 ()


  • Stationary basic diagnostic x-ray system, digital

FUJI IP CASSETTE CC - 04547410049565

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 15X30
In Commercial Distribution

  • 14547410049562 ()
  • 04547410049565 ()

  • 15X30 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049558

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 18X24cm
In Commercial Distribution

  • 14547410049555 ()
  • 04547410049558 ()

  • 18X24 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049541

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 24X30cm
In Commercial Distribution

  • 14547410049548 ()
  • 04547410049541 ()

  • 24X30 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049534

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 20.1X25.2cm(8X10)
In Commercial Distribution

  • 14547410049531 ()
  • 04547410049534 ()

  • 20.1X25.2 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049527

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 25.2X30.3cm(10X12)
In Commercial Distribution

  • 14547410049524 ()
  • 04547410049527 ()

  • 25.2X30.3 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049510

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BW 35.4X35.4cm(14X14)
In Commercial Distribution

  • 14547410049517 ()
  • 04547410049510 ()

  • 35.4X35.4 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049497

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 15X30
In Commercial Distribution

  • 14547410049494 ()
  • 04547410049497 ()

  • 15X30 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049480

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 18X24cm
In Commercial Distribution

  • 14547410049487 ()
  • 04547410049480 ()

  • 18X24 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049466

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 20.1X25.2cm(8X10)
In Commercial Distribution

  • 14547410049463 ()
  • 04547410049466 ()

  • 20.1X25.2 CM


  • Computed radiography digital imaging scanner

FUJI IP CASSETTE CC - 04547410049459

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 25.2X30.3cm(10X12)
In Commercial Distribution

  • 14547410049456 ()
  • 04547410049459 ()

  • 25.2X30.3 CM


  • Computed radiography digital imaging scanner

Scan eXam - 06430035872503

No Description
PaloDEx Group Oy
eXam5-1
In Commercial Distribution

  • 06430035872503 ()
900467

  • Radiography digital imaging scanner

GXPS-500 - 06430035872497

No Description
PaloDEx Group Oy
GXPS-500
Not in Commercial Distribution

  • 06430035872497 ()
900469

  • Dental computed radiography digital imaging scanner

DIGORA Optime - 06430035872480

No Description
PaloDEx Group Oy
DXR60
In Commercial Distribution

  • 06430035872480 ()
900682

  • Radiography digital imaging scanner

DIGORA Optime - 06430035872473

No Description
PaloDEx Group Oy
DXR50
In Commercial Distribution

  • 06430035872473 ()
900267

  • Radiography digital imaging scanner

Radlink Cassette - 00866389000198

The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation. This model is designed for 14"x17" plates.
RADLINK, INC.
CAS1417
In Commercial Distribution

  • 00866389000198 ()


  • Digital imaging cassette

Radlink Cassette - 00866389000181

The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation.This model is designed for 10"x12" plates.
RADLINK, INC.
CAS1012
In Commercial Distribution

  • 00866389000181 ()


  • Digital imaging cassette

Radlink CR Pro 2200 - 00866389000150

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

Radlink DR Pro 2200 - 00866389000143

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

Radlink GPS Tablet 2200 - 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.
TABLET
In Commercial Distribution

  • 00866389000112 ()


  • Radiology information system

Radlink GPS 2200 - 00866389000105

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

Radlink GPS Trauma - 00864908000162

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

Radlink GPS Tablet/Monitor Stand - 00864908000148

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.
RADLINK, INC.
M STAND
In Commercial Distribution

  • 00864908000148 ()


  • Computed radiography digital imaging scanner

Radlink PH GPS Bracket - 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.
PH BRACKET
In Commercial Distribution

  • 00864908000131 ()


  • Computed radiography digital imaging scanner

Radlink GPS Tablet Stand - 00864908000124

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.
RADLINK, INC.
STAND
In Commercial Distribution

  • 00864908000124 ()


  • Computed radiography digital imaging scanner

Radlink DR Tablet Retrofit - 00864908000100

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.
RADLINK, INC.
DRRETRO
In Commercial Distribution

  • 00864908000100 ()


  • Computed radiography digital imaging scanner

DR-ID 900MC - 04547410556452

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 900 MC W MDR E
In Commercial Distribution

  • 04547410556452 ()


  • Stationary basic diagnostic x-ray system, digital
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