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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 K183268
Device Name AI-Rad Companion (Cardiovascular)
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
malvern,  PA  19355
Applicant Contact kimberly rendon
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
malvern,  PA  19355
Correspondent Contact kimberly rendon
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/23/2018
Decision Date 09/10/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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