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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K251030
Device Name Sirona Advanced Imaging Suite
Applicant
Sirona Medical
171 2nd St.
San Francisco,  CA  94105
Applicant Contact Patrice Nedelec
Correspondent
Sirona Medical
171 2nd St.
San Francisco,  CA  94105
Correspondent Contact Patrice Nedelec
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/03/2025
Decision Date 10/22/2025
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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