SONOREAL 3D— 510(k) K012084

Substantially Equivalent

Bio Medi Com

FDA 510(k) clearance K012084 for SONOREAL 3D, Substantially Equivalent on 2001-09-26. Applicant: Bio Medi Com.

Clearance details

Applicant: Bio Medi Com
Product code: Code IYO
Advisory panel: Radiology
Date received: 2001-07-03
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, 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.