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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
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