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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 K230393
Device Name UniCam Evo Software
Applicant
Inter Medical Medizintechnik GmbH
Daimlerstrasse 34-36
Luebbecke,  DE D-32312
Applicant Contact Hans-Guenter Osiek
Correspondent
Inter Medical Medizintechnik GmbH
Daimlerstrasse 34-36
Luebbecke,  DE D-32312
Correspondent Contact Hans-Guenter Osiek
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/14/2023
Decision Date 04/13/2023
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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