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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K210760
Device Name Precise Image
Applicant
Philips Medical Systems Nederland, B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 PC
Applicant Contact Michael Chilbert
Correspondent
Philips Medical Systems Nederland, B.V.
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 PC
Correspondent Contact Michael Chilbert
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/15/2021
Decision Date 01/14/2022
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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