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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 B.V.
Veenpluis 6
BEST,  NL 5684 PC
Applicant Contact Maya Tolchinsky
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
BEST,  NL 5684 PC
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
Recalls CDRH Recalls
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