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FDA 510(k)

EchoGuide (Version 1)

K-Number: K243479 · 2025-04-23

ApplicantSonavex, Inc.
Decision Date2025-04-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoGuide (Version 1) is a medical device manufactured by Sonavex, Inc.. It received FDA 510(k) clearance on 2025-04-23 under approval number K243479. 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 EchoGuide (Version 1)?

EchoGuide (Version 1) is a medical device that received FDA 510(k) clearance on 2025-04-23. It is manufactured by Sonavex, Inc.. The 510(k) number is K243479.

When was EchoGuide (Version 1) approved by the FDA?

EchoGuide (Version 1) received FDA 510(k) clearance on 2025-04-23, under approval number K243479.

What company makes EchoGuide (Version 1)?

EchoGuide (Version 1) is manufactured by Sonavex, Inc..

What is the FDA product code for EchoGuide (Version 1)?

The FDA product code for EchoGuide (Version 1) is IYO.

Other Devices by Sonavex, Inc.

K180621EchoMark, EchoMark LP K190039EchoSure Diagnostic Ultrasound System

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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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