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510(k) K201798

myQA iON by Iba Dosimetry GmbH — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2020
Date Received
June 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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