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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 K170086
Device Name Pinnacle Radiation Therapy Planning System
Applicant
Philips Medical Systems (Cleveland), Inc.
5520 Nobel Dr.
Fitchburg,  WI  53711
Applicant Contact Michelle Godin
Correspondent
Philips Medical Systems (Cleveland), Inc.
5520 Nobel Dr.
Fitchburg,  WI  53711
Correspondent Contact Michelle Godin
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/10/2017
Decision Date 02/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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