PROTON THERAPY SYSTEM

System, Radiation Therapy, Charged-particle, Medical

ION BEAM APPLICATIONS S.A.

The following data is part of a premarket notification filed by Ion Beam Applications S.a. with the FDA for Proton Therapy System.

Pre-market Notification Details

Device IDK983024
510k NumberK983024
Device Name:PROTON THERAPY SYSTEM
ClassificationSystem, Radiation Therapy, Charged-particle, Medical
Applicant ION BEAM APPLICATIONS S.A. CENTRE SQUARE WEST, 38TH FLOOR Philadelphia,  PA  19102
ContactJohn B Reiss
CorrespondentJohn B Reiss
ION BEAM APPLICATIONS S.A. CENTRE SQUARE WEST, 38TH FLOOR Philadelphia,  PA  19102
Product CodeLHN  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-31
Decision Date2001-07-12
Summary:summary

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