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510(k) K191821

Blue Phantom PT by Iba Dosimetry GmbH — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2020
Date Received
July 8, 2019
Clearance Type
Abbreviated
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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