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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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Ambra PACS - AMBRHEALTHSOLUTIONS0

No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system

Ambra PACS - AMBRAPACS0

No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system

ArcScan Insight 100 - B017AS100

No Description
ARCSCAN, INC.
AS100
In Commercial Distribution

  • B017AS100 ()
AS100-120

  • Ophthalmic ultrasound imaging system

ArcScan Insight 100 - B017ED102

No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system

Sun Nuclear Mammo 156D Stereo Phantom - B136156D0

No Description
SUN NUCLEAR CORP.
156D
In Commercial Distribution

  • B136156D0 ()


  • Mammographic x-ray phantom, test object

Sun Nuclear Mammo 156 Phantom - B1361560

No Description
SUN NUCLEAR CORP.
156
In Commercial Distribution

  • B1361560 ()


  • Mammographic x-ray phantom, test object

WebPAX® - B127WP90

WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system

VisAR - B109VISAR2880

VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.88
In Commercial Distribution

  • B109VISAR2880 ()


  • Surgical planning/navigation-enhancement system

VisAR - B109VISAR2730

VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.73
In Commercial Distribution

  • B109VISAR2730 ()


  • Surgical planning/navigation-enhancement system

VisAR - B109VISAR2150

VisAR is the combination of augmented reality glasses and Novarad’s medical imaging software to create stereoscopic three-dimensional images acquired from CT sources.
Novarad Corporation
VisAR 2.1.5
In Commercial Distribution

  • B109VISAR2150 ()


  • Surgical planning/navigation-enhancement system
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