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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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

  • 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
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
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
No Description
PaloDEx Group Oy
DXR50
In Commercial Distribution

  • 06430035872473 ()
900267

  • Radiography digital imaging scanner
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK701G-WP
In Commercial Distribution

  • 00719192633148 ()
17HK701G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK700G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK700G-WP
In Commercial Distribution

  • 00719192633131 ()
17HK700G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
14HK701G-WP
In Commercial Distribution

  • 00719192633124 ()
14HK701G-WP

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK701G-W
In Commercial Distribution

  • 00719192633117 ()
17HK701G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
17HK700G-W
In Commercial Distribution

  • 00719192620766 ()
17HK700G-WA

  • Indirect flat panel x-ray detector
No Description
LG Electronics Inc.
14HK701G-W
In Commercial Distribution

  • 00719192620759 ()
14HK701G-WA

  • Indirect flat panel x-ray detector
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
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