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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K221921
Device Name DTX Studio Clinic 3.0
Applicant
Nobel Biocare AB
Vastra Hamngatan 1
411 17 Goteborg,  SE 402 26
Applicant Contact Wim Vrydag
Correspondent
Nobel Biocare c/o Medicim NV
Stationsstraat 102
Mechelen,  BE 2800
Correspondent Contact Wim Vrydag
Regulation Number892.2070
Classification Product Code
MYN  
Date Received07/01/2022
Decision Date 03/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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