UltraVision 2 Diagnostic Ultrasound System
K-Number: K173265 · 2017-11-07
ApplicantWinprobe Corporation
Decision Date2017-11-07
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UltraVision 2 Diagnostic Ultrasound System is a medical device manufactured by Winprobe Corporation. It received FDA 510(k) clearance on 2017-11-07 under approval number K173265. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UltraVision 2 Diagnostic Ultrasound System?
UltraVision 2 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by Winprobe Corporation. The 510(k) number is K173265.
When was UltraVision 2 Diagnostic Ultrasound System approved by the FDA?
UltraVision 2 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-11-07, under approval number K173265.
What company makes UltraVision 2 Diagnostic Ultrasound System?
UltraVision 2 Diagnostic Ultrasound System is manufactured by Winprobe Corporation.
What is the FDA product code for UltraVision 2 Diagnostic Ultrasound System?
The FDA product code for UltraVision 2 Diagnostic Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.