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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 K252214
Device Name AIAS Cephalon
Applicant
Metamorphosis GmbH
Technologiepark 9
Paderborn,  DE 33100
Applicant Contact Dr. Stefanie Horstmann
Correspondent
Metamorphosis GmbH
Technologiepark 9
Paderborn,  DE 33100
Correspondent Contact Dr. Stefanie Horstmann
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/15/2025
Decision Date 10/07/2025
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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