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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 K203374
Device Name X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)
Applicant
De Götzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Applicant Contact Dario Bandiera
Correspondent
De Götzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Correspondent Contact Dario Bandiera
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/16/2020
Decision Date 02/05/2021
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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