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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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Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
Precision i5
In Commercial Distribution

  • 07350008750098 ()


  • Stationary basic diagnostic x-ray system, digital
Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital
Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0072
In Commercial Distribution

  • 07350008750012 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
Thought Technology Ltd.
SA2600
In Commercial Distribution

  • 07540191000081 ()


  • Psychophysiological biofeedback system
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
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
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