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510(k) K191521

Radiance 330 Proton Beam Therapy System by Protom International Holding Corporation — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2019
Date Received
June 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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