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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 K193454
Device Name IQon Spectral CT
Applicant
Philips Medical Systems, Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Applicant Contact Nimit Shah
Correspondent
Philips Medical Systems, Nederland B.V.
Veenpluis 4-6
Best,  NL 5684 PC
Correspondent Contact Nimit Shah
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/13/2019
Decision Date 01/24/2020
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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