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510(k) K243479

EchoGuide (Version 1) by Sonavex, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Sonavex, Inc.

  • K190039 — EchoSure Diagnostic Ultrasound System (March 8, 2019)
  • K180621 — EchoMark, EchoMark LP (June 6, 2018)

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  • K242496 — Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) (November 19, 2024)