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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 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
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution

  • 03760415600000 ()


  • Ultrasound imaging system application software
Navident Procedure Kit - for use with the Navident System (955-ND-ND).
Claronav Inc
955-ND-PRK
In Commercial Distribution

  • 07540209990021 ()


  • Surgical planning/navigation-enhancement system
Navident Surgical Navigation System
Claronav Inc
955-ND-ND
In Commercial Distribution

  • 07540209990014 ()


  • Surgical planning/navigation-enhancement system
NaviTray
Claronav Inc
955-ND-NTRY
In Commercial Distribution

  • 07540209955921 ()
955-ND-NTRY

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT43)
Claronav Inc
955-ND-JTTB-001
In Commercial Distribution

  • 07540209955914 ()
955-ND-JTTB-001

  • Surgical planning/navigation-enhancement system
JawTracker T (JTT42)
Claronav Inc
955-ND-JTTC-001
In Commercial Distribution

  • 07540209955907 ()
955-ND-JTTC-001

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT41)
Claronav Inc
955-ND-JTTA-001
In Commercial Distribution

  • 07540209955891 ()
955-ND-JTTA-001

  • Surgical planning/navigation-enhancement system
Jaw Tracker 4U
Claronav Inc
955-ND-JTUC
In Commercial Distribution

  • 07540209955884 ()
955-ND-JTUC

  • Surgical planning/navigation-enhancement system
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