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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 K201798
Device Name myQA iON
Applicant
Iba Dosimetry GmbH
Bahnhofstrasse 5
Schwarzenbruck,  DE D-90592
Applicant Contact Andreas Suchi
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.5050
Classification Product Code
LHN  
Subsequent Product Code
IYE  
Date Received06/30/2020
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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