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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
Predetermined Change
Control Plan Authorized		 No
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