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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
Recalls CDRH Recalls
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