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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 K253902
Device Name RealGUIDE
Applicant
3DIEMME SRL
Via Risorgimento 9
Cantù,  IT 21047
Applicant Contact Alesandro Avis
Correspondent
3DIEMME SRL
Via Risorgimento 9
Cantù,  IT 21047
Correspondent Contact Alesandro Avis
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received12/05/2025
Decision Date 08/04/2026
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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