FDA 510(k)

Vu-Path Ultrasound System

K-Number: K203657 · 2021-06-25

Decision Date2021-06-25

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vu-Path Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Crystalline Medical. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K203657. 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 Vu-Path Ultrasound System?

Vu-Path Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Crystalline Medical. The 510(k) number is K203657.

When did Vu-Path Ultrasound System receive FDA 510(k) clearance?

Vu-Path Ultrasound System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K203657.

Who is the listed applicant for Vu-Path Ultrasound System?

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

What is the FDA product code for Vu-Path Ultrasound System?

The FDA product code for Vu-Path 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.