INVISION SYSTEM— 510(k) K083728

Substantially Equivalent

Inneroptic Technology, Inc.

FDA 510(k) clearance K083728 for INVISION SYSTEM, Substantially Equivalent on 2009-08-12. Applicant: Inneroptic Technology, Inc..

Clearance details

Applicant: Inneroptic Technology, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2008-12-16
Decision date: 2009-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsborough, NC, 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.