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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 K232899
Device Name AI-Rad Companion Organs RT
Applicant
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Applicant Contact Kira Morales
Correspondent
Siemens Medical Solutions U.S.A.
40 Liberty Blvd.
Malvern,  PA  19355
Correspondent Contact Kira Morales
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/18/2023
Decision Date 04/03/2024
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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