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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 K214081
Device Name MRCAT Head & Neck
Applicant
Philips OY
Ayritie 4
Vantaa,  FI 01510
Applicant Contact Janne Marvola
Correspondent
Philips OY
Ayritie 4
Vantaa,  FI 01510
Correspondent Contact Anne-Sophie Glantenay
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/27/2021
Decision Date 04/05/2022
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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