SONOREAL 3D— 510(k) K023473

Name: FDA 510(k) clearance K023473
Creator: U.S. Food and Drug Administration
Published: 2002-11-20

Substantially Equivalent

Bio Medi Com

FDA 510(k) clearance K023473 for SONOREAL 3D, Substantially Equivalent on 2002-11-20. Applicant: Bio Medi Com. Device class: 2.

Clearance details

Applicant: Bio Medi Com
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2002-10-16
Decision date: 2002-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

Download summary PDF View on FDA.gov ↗

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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.