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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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