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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K132847
Device Name I2C
Applicant
ION BEAM APPLICATIONS S.A.
1500 MARKET STREET
CENTRE SQUARE WEST, 38TH FLOOR
PHILADELPHIA,  PA  19102
Applicant Contact BRUCE D ARMON
Correspondent
ION BEAM APPLICATIONS S.A.
1500 MARKET STREET
CENTRE SQUARE WEST, 38TH FLOOR
PHILADELPHIA,  PA  19102
Correspondent Contact BRUCE D ARMON
Regulation Number892.5050
Classification Product Code
LHN  
Date Received09/11/2013
Decision Date 11/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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