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GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution
- 00840682123501 ()
- 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
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
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
Loudspeaker for KARL STORZ VOICE1®
Karl Storz GmbH & Co. KG
20090073
In Commercial Distribution
- 04048551006733 ()
- Operating room audiovisual data/device management system application software
EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.
EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.
EKF Link facilitates the setting of configurable options of connected analyzers.
EKF-diagnostic GmbH
0760-0101
In Commercial Distribution
- 04048534002011 ()
0760-0101
- Laboratory instrument/analyser application software IVD
Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution
- 10385083000565 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system
Omnipod 5 Pod
Insulet Corporation
POD-OMNI-I1-6720
In Commercial Distribution
- 20385083000531 ()
- 10385083000527 ()
- 20385083000579 ()
- 20385083000753 ()
- Ambulatory insulin infusion pump/interstitial glucose monitoring system