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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
Recalls CDRH Recalls
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