ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM— 510(k) K103425

Substantially Equivalent

Genoray America, Inc.

FDA 510(k) clearance K103425 for ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM, Substantially Equivalent on 2011-03-29. Applicant: Genoray America, Inc..

Clearance details

Applicant: Genoray America, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2010-11-22
Decision date: 2011-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.