OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500— 510(k) K100691

Name: FDA 510(k) clearance K100691
Creator: U.S. Food and Drug Administration
Published: 2010-05-11

Substantially Equivalent

Bionix Development Corp.

FDA 510(k) clearance K100691 for OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500, Substantially Equivalent on 2010-05-11. Applicant: Bionix Development Corp.. Device class: 2.

Clearance details

Applicant: Bionix Development Corp.
Product code: Code IYE
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2010-03-10
Decision date: 2010-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, 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.