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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 K161807
Device Name BEAMSCAN
Applicant
Ptw-Freiburg Physikalisch Technische-Werksraetten
Dr. Pychlau Gmbh
Loerracher St. 7
Freiburg,  DE 79115
Applicant Contact Sandor-Csaba Ats
Correspondent
Ptw-Freiburg Physikalisch Technische-Werksraetten
Dr. Pychlau Gmbh
Loerracher St. 7
Freiburg,  DE 79115
Correspondent Contact Sandor-Csaba Ats
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/01/2016
Decision Date 05/19/2017
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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