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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K162190
Device Name Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (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 Number872.1800
Classification Product Code
MUH  
Date Received08/04/2016
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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