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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 K120363
Device Name SYNGO RT INTERFACE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord,  CA  94520
Applicant Contact christine dunbar
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord,  CA  94520
Correspondent Contact christine dunbar
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
LLZ  
Date Received02/06/2012
Decision Date 03/20/2012
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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