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FDA 510(k)

SonicEye Dual-Array Ultrasound System

K-Number: K192253 · 2020-02-25

ApplicantSonivate Medical, Inc.
Decision Date2020-02-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SonicEye Dual-Array Ultrasound System is a medical device manufactured by Sonivate Medical, Inc.. It received FDA 510(k) clearance on 2020-02-25 under approval number K192253. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SonicEye Dual-Array Ultrasound System?

SonicEye Dual-Array Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-02-25. It is manufactured by Sonivate Medical, Inc.. The 510(k) number is K192253.

When was SonicEye Dual-Array Ultrasound System approved by the FDA?

SonicEye Dual-Array Ultrasound System received FDA 510(k) clearance on 2020-02-25, under approval number K192253.

What company makes SonicEye Dual-Array Ultrasound System?

SonicEye Dual-Array Ultrasound System is manufactured by Sonivate Medical, Inc..

What is the FDA product code for SonicEye Dual-Array Ultrasound System?

The FDA product code for SonicEye Dual-Array Ultrasound System is IYO.

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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.

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