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510(k) K101038

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER by Acceletronics Digital Imaging, LLC — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2010
Date Received
April 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

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