Dolphin/IQ, Dolphin/4D And Dolphin/MAX With Dolphin/XF Robot Accessory

System, Imaging, Pulsed Doppler, Ultrasonic

Viasonix Ltd.

The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Dolphin/iq, Dolphin/4d And Dolphin/max With Dolphin/xf Robot Accessory.

Pre-market Notification Details

Device IDK202742
510k NumberK202742
Device Name:Dolphin/IQ, Dolphin/4D And Dolphin/MAX With Dolphin/XF Robot Accessory
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Viasonix Ltd. 10 Hamelacha Street Raananna,  IL 4366105
ContactDan Manor
CorrespondentDan Manor
Viasonix Ltd. 10 Hamelacha Street Raanana,  IL 4366105
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeOQQ
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-18
Decision Date2021-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016880229 K202742 000

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