IVIEW— 510(k) K053306

Substantially Equivalent

Ondemandsoft

FDA 510(k) clearance K053306 for IVIEW, Substantially Equivalent on 2006-04-19. Applicant: Ondemandsoft.

Clearance details

Applicant: Ondemandsoft
Product code: Code IYO
Advisory panel: Radiology
Date received: 2005-11-28
Decision date: 2006-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.