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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K222977
Device Name DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
Applicant
Macromedics BV
Oostbaan 670
Moordrecht,  NL 2841 ML
Applicant Contact Elizabeth Hajos
Correspondent
Macromedics BV
Oostbaan 670
Moordrecht,  NL 2841 ML
Correspondent Contact Elizabeth Hajos
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received09/28/2022
Decision Date 02/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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