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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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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
SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasound equipment through a Sonio Edge Software installed in the HCP network that can send and upload media sent by the Ultrasound equipments in DICOM format, act as a Worklist for those Ultrasound equipments as well as interact with the IT solutions of the HCP through HL7 protocol (interoperability with the EMR, Billing System, ...) .
SONIO
2
In Commercial Distribution

  • 03770024341010 ()


  • Medical image management system
No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017100159 ()


  • Nitrogen plasma skin surface treatment system
No Description
GENORAY CO., LTD.
ZEN-PX4
In Commercial Distribution

  • 08809244061226 ()


  • Portable basic diagnostic x-ray system, digital
No Description
GENORAY CO., LTD.
PORT-X IV
In Commercial Distribution

  • 08809244061202 ()


  • Portable basic diagnostic x-ray system, digital
The Multiple Name for PORT-XII is ZEN-PX2.
GENORAY CO., LTD.
PORT-XII
In Commercial Distribution

  • 08809244061035 ()


  • Portable basic diagnostic x-ray system, digital
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1019
In Commercial Distribution

  • 00889024624887 ()
AI1019

  • Medical image management system
No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024596184 ()
AI1000

  • Medical image management system
No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical
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