EchoGuide (Version 1)— 510(k) K243479

Substantially Equivalent

Sonavex, Inc.

FDA 510(k) clearance K243479 for EchoGuide (Version 1), Substantially Equivalent on 2025-04-23. Applicant: Sonavex, Inc..

Clearance details

Applicant: Sonavex, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2024-11-08
Decision date: 2025-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.