OTI-SCAN 3000— 510(k) K092837

Substantially Equivalent

Opko Instrumentation, Inc.

FDA 510(k) clearance K092837 for OTI-SCAN 3000, Substantially Equivalent on 2009-12-23. Applicant: Opko Instrumentation, Inc..

Clearance details

Applicant: Opko Instrumentation, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2009-09-15
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, 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.