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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 K193109
Device Name MRCAT brain
Applicant
Philips Medical Systems MR Finland
Ayritie 4
Vantaa,  FI 01510
Applicant Contact Janne Marvola
Correspondent
Philips Medical Systems MR Finland
Ayritie 4
Vantaa,  FI 01510
Correspondent Contact Janne Marvola
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/08/2019
Decision Date 01/24/2020
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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