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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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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
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
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
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.17
In Commercial Distribution

  • 00854344007764 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.16
In Commercial Distribution

  • 00854344007757 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.15
In Commercial Distribution

  • 00854344007740 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.14
In Commercial Distribution

  • 00854344007733 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.13
In Commercial Distribution

  • 00854344007726 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.12
In Commercial Distribution

  • 00854344007696 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR, v4.10
In Commercial Distribution

  • 00854344007672 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.5.0
In Commercial Distribution

  • 00854344007436 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.2.0
In Commercial Distribution

  • 00854344007405 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007290 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
v4.0.1
In Commercial Distribution

  • 00854344007283 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus DR v4.1.0
In Commercial Distribution

  • 00854344007221 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.2
In Commercial Distribution

  • 00854344007184 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
Nexus, DR, v3.1
In Commercial Distribution

  • 00854344007016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 311
In Commercial Distribution

  • 00851354007142 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 310
In Commercial Distribution

  • 00851354007135 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 309
In Commercial Distribution

  • 00851354007128 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 308
In Commercial Distribution

  • 00851354007111 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 307
In Commercial Distribution

  • 00851354007104 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 306
In Commercial Distribution

  • 00851354007098 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 305
In Commercial Distribution

  • 00851354007081 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 304
In Commercial Distribution

  • 00851354007074 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 303
In Commercial Distribution

  • 00851354007067 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 302
In Commercial Distribution

  • 00851354007050 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 301
In Commercial Distribution

  • 00851354007043 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 204
In Commercial Distribution

  • 00851354007036 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 203
In Commercial Distribution

  • 00851354007029 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 202
In Commercial Distribution

  • 00851354007012 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 201
In Commercial Distribution

  • 00851354007005 ()


  • Flat panel x-ray detector integration unit
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
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
17HQ901G-BP
In Commercial Distribution

  • 00195174039687 ()
17HQ901G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
14HQ901G-BP
In Commercial Distribution

  • 00195174039663 ()
14HQ901G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 10HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
10HQ701G-BP
In Commercial Distribution

  • 00195174039496 ()
10HQ701G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
17HQ701G-BP
In Commercial Distribution

  • 00195174039472 ()
17HQ701G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
14HQ701G-BP
In Commercial Distribution

  • 00195174039458 ()
14HQ701G-BP

  • Indirect flat panel x-ray detector
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