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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 K222361
Device Name AI-Rad Companion (Musculoskeletal)
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Kira Kuzmenchuk
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Kira Kuzmenchuk
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/04/2022
Decision Date 10/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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