PROTON THERAPY SYSTEM— 510(k) K062891

Name: FDA 510(k) clearance K062891
Creator: U.S. Food and Drug Administration
Published: 2006-12-14

Substantially Equivalent

Indiana University Cyclotron Facility

FDA 510(k) clearance K062891 for PROTON THERAPY SYSTEM, Substantially Equivalent on 2006-12-14. Applicant: Indiana University Cyclotron Facility. Device class: 2.

Clearance details

Applicant: Indiana University Cyclotron Facility
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2006-09-26
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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