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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
Philips Oy
Ayritie 4
Vantaa,  FI 01510
Applicant Contact Janne Marvola
Philips Oy
Ayritie 4
Vantaa,  FI 01510
Correspondent Contact Anne-Sophie Glantenay
Regulation Number892.5050
Classification Product Code
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