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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K162955
FOIA Releasable 510(k) K162955
Device Name Multi-Modality Tumor Tracking (MMTT) application
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 Pc Best
Best Noord-Brabant,  NL 5684 PC
Applicant Contact Yoram Levy
Correspondent
Qsite
31 Haavoda St.
Binyamina,  IL 30500
Correspondent Contact Yoram Levy
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/24/2016
Decision Date 12/19/2016
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
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