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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K101220
Device Name EXPLORER 4D TREATMENT PLANNING SYSTEM
Applicant
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Applicant Contact DAN OLIVER
Correspondent
AMERICAN RADIOSURGERY, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO,  CA  92128
Correspondent Contact DAN OLIVER
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/03/2010
Decision Date 11/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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