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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252571
Device Name mdprostate
Applicant
Mediaire GmbH
Moeckernstrasse 63
Berlin,  DE 10965
Applicant Contact Wegener Alexander
Correspondent
Mediaire GmbH
Ritterstrasse 16-18
Berlin,  DE 10969
Correspondent Contact Wegener Alexander
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/14/2025
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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