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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 K191944
Device Name MU2net
Applicant
Dosisoft
45/47 Ave. Carnot
Cachan,  FR 94230
Applicant Contact Marc Usynski
Correspondent
Dosisoft
45/47 Ave. Carnot
Cachan,  FR 94230
Correspondent Contact Luc Diot
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/22/2019
Decision Date 10/24/2019
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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