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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
iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD
U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution

  • 03610520178904 ()

  • 1 Each
12003844

  • Laboratory instrument/analyser application software IVD
No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0071-0101
In Commercial Distribution

  • 04049016148708 ()


  • Laboratory instrument/analyser application software IVD
No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791261 ()


  • MRI system application software
No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software
No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software
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