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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 K173588
Device Name Illumeo System
Philips Medical Systems Technologies, Ltd.
PO Box 325
Building 34
Haifa,  IL 3100202
Applicant Contact Yoram Levy
Philips Medical Systems Technologies Ltd.
31 Haavoda Street
Binyamina,  IL 3100202
Correspondent Contact Yoram Levy
Regulation Number892.2050
Classification Product Code
Subsequent Product Code
Date Received11/20/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No