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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K221305
Device Name AI-Rad Companion Organs RT
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-3
Malvern,  PA  19355
Applicant Contact Kira Kuzmenchuk
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Blvd.
Mail Code 65-3
Malvern,  PA  19355
Correspondent Contact Kira Kuzmenchuk
Regulation Number892.2050
Classification Product Code
QKB  
Date Received05/05/2022
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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