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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
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