IBA PROTON THERAPY SYSTEM-PROTEUS 235— 510(k) K053641

Name: FDA 510(k) clearance K053641
Creator: U.S. Food and Drug Administration
Published: 2006-01-24

Substantially Equivalent

Ion Beam Applications S.A.

FDA 510(k) clearance K053641 for IBA PROTON THERAPY SYSTEM-PROTEUS 235, Substantially Equivalent on 2006-01-24. Applicant: Ion Beam Applications S.A.. Device class: 2.

Clearance details

Applicant: Ion Beam Applications S.A.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2005-12-30
Decision date: 2006-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

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