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510(k) K131777

HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM by Hyper Technology, Inc. — Product Code IWB

K131777 is an FDA 510(k) premarket notification submitted by Hyper Technology, Inc. for the device "HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM". The FDA issued a decision of Substantially Equivalent on February 28, 2014. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2014
Date Received
June 17, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

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FDA data resources