FDA 510(k)

UltraVision 2 Diagnostic Ultrasound System

K-Number: K173265 · 2017-11-07

Decision Date2017-11-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UltraVision 2 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Winprobe Corporation. It received FDA 510(k) clearance on 2017-11-07 under 510(k) 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. The listed applicant is Winprobe Corporation. The 510(k) number is K173265.

When did UltraVision 2 Diagnostic Ultrasound System receive FDA 510(k) clearance?

UltraVision 2 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-11-07, under 510(k) number K173265.

Who is the listed applicant for UltraVision 2 Diagnostic Ultrasound System?

The FDA 510(k) record lists Winprobe Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraVision 2 Diagnostic Ultrasound System?

The FDA product code for UltraVision 2 Diagnostic Ultrasound System is IYN.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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