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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K231898
Device Name DTX Studio Clinic (4.0)
Applicant
Nobel Biocare AB
Box 5190, 402 26
Västra Hamngatan 1
Göteborg,  SE 411 17
Applicant Contact Mieke Roelants
Correspondent
Nobel Biocare c/o Medicim NV
Stationsstraat 102
Mechelen,  BE 2800
Correspondent Contact Mieke Roelants
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
MYN  
Date Received06/28/2023
Decision Date 12/08/2023
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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