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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K191821
Device Name Blue Phantom PT
Applicant
Iba Dosimetry GmbH
Bahnhofstr. 5
Schwarzenbruck,  DE 90592
Applicant Contact Andreas Suchi
Correspondent
Tuv Sud America, Inc.
1775 Old Hwy. 8 NW
New Brighton,  MN  55112
Correspondent Contact Olaf Teichert
Regulation Number892.5050
Classification Product Code
LHN  
Date Received07/08/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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