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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 K212875
Device Name Spectral CT on Rails
Applicant
Philips Medical Systems Nederland BV
Veenpluis 6
5684 Pc
Best,  NL
Applicant Contact Maya Tolchinsky
Correspondent
Philips Medical Systems Nederland BV
Veenpluis 6
5684 Pc
Best,  NL
Correspondent Contact Maya Tolchinsky
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/09/2021
Decision Date 05/13/2022
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
Recalls CDRH Recalls
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