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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 K180601
Device Name Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
Applicant
Villa Sistemi Medicali S.P.A.
Via Delle Azalee 3
Buccinasco,  IT I-20090
Applicant Contact Paolo Casagrande Santin
Correspondent
Villa Sistemi Medicali S.P.A.
Via Delle Azalee 3
Buccinasco,  IT I-20090
Correspondent Contact Paolo Casagrande Santin
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/07/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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