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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K252353
Device Name myray ProXIma X6
Applicant
Cefla S.C.
Via Selice Provinciale 23/A
Imola (Bo),  IT 40026
Applicant Contact Simona Daidone
Correspondent
Cefla S.C.
Via Selice Provinciale 23/A
Imola (Bo),  IT 40026
Correspondent Contact Ilenia Muccione
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received07/29/2025
Decision Date 03/10/2026
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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