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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 GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A
In Commercial Distribution

  • 08806088566313 ()


  • Stationary basic diagnostic x-ray system, digital
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC85A
In Commercial Distribution

  • 08806088565231 ()


  • Stationary basic diagnostic x-ray system, digital
The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GU60A-65
In Commercial Distribution

  • 08806088520971 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50A
In Commercial Distribution

  • 08806088351889 ()


  • Stationary basic diagnostic x-ray system, digital
The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF50
In Commercial Distribution

  • 08806088351872 ()


  • Stationary basic diagnostic x-ray system, digital
The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital
Hand Diagnostic Radiography Imaging System
NANORAY BIOTECH CO., LTD.
NDR705
In Commercial Distribution

  • 04719892352000 ()


  • Stationary basic diagnostic x-ray system, digital
The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
Halifax Biomedical Incorporated
1
In Commercial Distribution

  • 00628451892021 ()
P008943

  • Stationary basic diagnostic x-ray system, digital
DIGITAL RADIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
DRAD-3000E
In Commercial Distribution

  • 04987670102196 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
Siemens Shanghai Medical Equipment Ltd.
11333888
In Commercial Distribution

  • 04056869279985 ()


  • Stationary basic diagnostic x-ray system, digital
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