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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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No Description
GE Vingmed Ultrasound AS
Software Only v203
In Commercial Distribution

  • 00840682141703 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v203
In Commercial Distribution

  • 00840682141697 ()


  • Ultrasound imaging system application software
GRAFT SIZER, 6.5 MM
Conmed Corporation
8790
In Commercial Distribution

  • 10845854025680 ()
  • 20845854025687 ()
8790

  • Ligament graft sizer, noninvasive
Vscan Air for Android
GE Vingmed Ultrasound AS
Air for Android
In Commercial Distribution

  • 00840682147101 ()


  • Ultrasound imaging system application software
Vscan Air for iOS
GE Vingmed Ultrasound AS
Air for iOS
In Commercial Distribution

  • 00840682147071 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v204
In Commercial Distribution

  • 00840682146883 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v204
In Commercial Distribution

  • 00840682146876 ()


  • Ultrasound imaging system application software
Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
DIAGNOLY
1
In Commercial Distribution

  • 03770033463000 ()


  • Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following: Automatically detect views; Automatically detect anatomical structures within the supported views; Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria
SONIO
2
In Commercial Distribution

  • 03770024341041 ()


  • Ultrasound imaging system application software
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol.
SONIO
1
In Commercial Distribution

  • 03770024341027 ()


  • Ultrasound imaging system application software
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