OMNIPRO INCLINE— 510(k) K092018

Name: FDA 510(k) clearance K092018
Creator: U.S. Food and Drug Administration
Published: 2009-09-18

Substantially Equivalent

Iba Dosimetry GmbH

FDA 510(k) clearance K092018 for OMNIPRO INCLINE, Substantially Equivalent on 2009-09-18. Applicant: Iba Dosimetry GmbH. Device class: 2.

Clearance details

Applicant: Iba Dosimetry GmbH
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2009-07-06
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.