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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 K252195
Device Name ARTICOR planner
Applicant
Artiness S.R.L
Viale Cassale, 57
Milan,  IT 20143
Applicant Contact Monica R. Montanez
Correspondent
Namsa
6750 Wales Rd.
Toledo,  OH  43619
Correspondent Contact Monica R. Montanez
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/14/2025
Decision Date 03/27/2026
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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