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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 K191719
Device Name X-MIND Trium
Applicant
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Applicant Contact Dario Bandiera
Correspondent
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Correspondent Contact Dario Bandiera
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
OAS  
Date Received06/26/2019
Decision Date 02/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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