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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X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1717WCE-HS
In Commercial Distribution

  • 08800018602232 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HS
In Commercial Distribution

  • 08800018602164 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE
In Commercial Distribution

  • 08800018602140 ()


  • Indirect flat panel x-ray detector
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321374 ()
6101BR Size 2 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321367 ()
6101BR Size 1 Replacement

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321350 ()
6100B Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321343 ()
6100B Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321336 ()
6101AR Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321329 ()
6100AR Size 1

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321312 ()
6101A Size 2

  • Dental digital imaging sensor, intraoral
This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator.
Tuxedo Imaging LLC
TUXEDO INTRAORAL SENSOR
In Commercial Distribution

  • 00860008321305 ()
6100A Size 1

  • Dental digital imaging sensor, intraoral
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
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
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
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
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
No Description
INFIMED, INC.
3.0
Not in Commercial Distribution

  • 00858086006115 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
Nexus DR
Not in Commercial Distribution

  • 00858086006092 ()


  • X-ray system computer, diagnostic, general-purpose
Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.
OSKO, INC.
Edge Air
In Commercial Distribution

  • 00869126000444 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images.
OSKO, INC.
Edge
In Commercial Distribution

  • 00869126000437 ()


  • Indirect flat panel x-ray detector
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
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 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
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
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 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
PORTABLE WORKSTATION Wirelessly Transfer Images Directly to PACS, Ultra-light, and Portable, Design tested to handle, water, dust, and splash resistance The DELWORKS FIT portable tablet workstation aims to maximize the portability and efficiency of the DELWORKS software - utilizing it anytime, anywhere.
Del Medical, Inc.
3.0
In Commercial Distribution

  • 00858340006097 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
PaloDEx Group Oy
eXam5-1
In Commercial Distribution

  • 06430035872503 ()
900467

  • Radiography digital imaging scanner
No Description
PaloDEx Group Oy
GXPS-500
Not in Commercial Distribution

  • 06430035872497 ()
900469

  • Dental computed radiography digital imaging scanner
No Description
PaloDEx Group Oy
DXR60
In Commercial Distribution

  • 06430035872480 ()
900682

  • Radiography digital imaging scanner
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