Enovare Ultrasound System— 510(k) K153620

Substantially Equivalent

Oreon Technologies, Inc.

FDA 510(k) clearance K153620 for Enovare Ultrasound System, Substantially Equivalent on 2016-05-05. Applicant: Oreon Technologies, Inc..

Clearance details

Applicant: Oreon Technologies, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2015-12-18
Decision date: 2016-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harrytown, NY, 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.