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 device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting.
CLEAR GUIDE MEDICAL, INC.
CGOHM
In Commercial Distribution

  • B201CGOHM0 ()
  • B201CGOHM1 ()
CG-OH-M

  • Radiological video camera patient positioning/tracking system camera
  • Optical surgical navigation device tracking system
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Epica Medical Innovations LLC
9801101000
Not in Commercial Distribution

  • 86000594161101 ()
86000594161101

  • Cone beam computed tomography system, head/neck
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
In Commercial Distribution

  • 47630039301444 ()


  • CT contrast medium injection system, line-powered, stationary
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
In Commercial Distribution

017285

  • CT contrast medium injection system, line-powered, stationary
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
Bracco Injeneering SA
017285
Not in Commercial Distribution



  • CT contrast medium injection system, line-powered, stationary
The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.
UIH TECHNOLOGIES LLC
uMI 550 VM
In Commercial Distribution

  • 00810030350095 ()


  • PET/CT system
The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.
UIH TECHNOLOGIES LLC
uMI 550
In Commercial Distribution

  • 00810030350088 ()


  • PET/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 316
In Commercial Distribution

  • 07290108670226 ()
8010419-01

  • SPECT/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 364
In Commercial Distribution

  • 07290108670219 ()
8010420-01

  • SPECT/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 464
In Commercial Distribution

  • 07290108670189 ()
8010422-01

  • SPECT/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 416
In Commercial Distribution

  • 07290108670172 ()
8010421-01

  • SPECT/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging.
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 16
In Commercial Distribution

  • 07290108670127 ()
8010172-01

  • SPECT/CT system
Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging,
SPECTRUM DYNAMICS MEDICAL, INC
VERITON CT 64
In Commercial Distribution

  • 07290108670110 ()
8010142-01

  • SPECT/CT system
No Description
Neusoft Medical Systems Co., Ltd.
NeuViz Prime
Not in Commercial Distribution

  • 06970167440077 ()


  • Full-body CT system
No Description
Neusoft Medical Systems Co., Ltd.
NeuSight PET/CT 64
Not in Commercial Distribution

  • 06970167440053 ()


  • PET/CT system
No Description
Neusoft Medical Systems Co., Ltd.
NeuSight PET/CT 16
Not in Commercial Distribution

  • 06970167440060 ()


  • PET/CT system
Positron Emission Tomography and Computed Tomography System
Shanghai United Imaging Healthcare Co., Ltd.
uMI 550
In Commercial Distribution

  • 06971576832026 ()


  • PET/CT system
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama GS
In Commercial Distribution

  • 06971576832187 ()


  • PET/CT system
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama 35
In Commercial Distribution

  • 06971576832170 ()


  • PET/CT system
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMI 550
In Commercial Distribution

  • 06971576832057 ()


  • PET/CT system
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