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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NOVA CSAP Ceiling suspension tube stand Motorized with Auto positioning and touch screen panel (to work with auto position table and wall stand versions).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5200
In Commercial Distribution

  • 00817100020094 ()


  • Stationary basic diagnostic x-ray system, digital
Manual ceiling suspension tube stand ONLY
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR5100
In Commercial Distribution

  • 00817100020070 ()


  • Stationary basic diagnostic x-ray system, digital
Floor-Mounted Tubestand longitudinal tube travel 2m. with advanced control with Digital SID
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR100
In Commercial Distribution

  • 00817100020063 ()


  • Stationary basic diagnostic x-ray system, digital
Advanced Universal U-arm Stand 4000 - Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3500B
In Commercial Distribution

  • 00817100020056 ()


  • Stationary basic diagnostic x-ray system, digital
Advanced Universal U-arm Stand 3000 - 8' Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3002
In Commercial Distribution

  • 00817100020049 ()


  • Stationary basic diagnostic x-ray system, digital
Universal U-arm system - With Motorized Auto Positioning and Touchscreen control
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3000
In Commercial Distribution

  • 00817100020032 ()


  • Stationary basic diagnostic x-ray system, digital
Universal U-arm system - Motorized.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR3001
In Commercial Distribution

  • 00817100020025 ()


  • Stationary basic diagnostic x-ray system, digital
Universal Radiographic Straight Arm system variable focal distance left loading Only.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR1000
In Commercial Distribution

  • 00817100020018 ()


  • Stationary basic diagnostic x-ray system, digital
CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital
RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220522 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220454 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220423 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220416 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220409 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220393 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220386 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220324 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
AcuitySDR
In Commercial Distribution

  • 00810035220102 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
AcuitySDR
In Commercial Distribution

  • 00810035220096 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
AcuitySDR+
In Commercial Distribution

  • 00810035220089 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
AcuitySDR+
In Commercial Distribution

  • 00810035220072 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
AcuitySDR+
In Commercial Distribution

  • 00810035220065 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220027 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220010 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220317 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220058 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220041 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Standard
In Commercial Distribution

  • 00810035220034 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
RADMEDIX, LLC
Plus
In Commercial Distribution

  • 00810035220003 ()


  • Stationary basic diagnostic x-ray system, digital
The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.
UIH TECHNOLOGIES LLC
uDR 780i
In Commercial Distribution

  • 00810030350071 ()


  • Stationary basic diagnostic x-ray system, digital
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