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510(k) K102533

ROTATING GAMMA SYSTEM INFINI (INFINI) by Masep Medical Science & Tech.Development (Shenzhen — Product Code IWB

K102533 is an FDA 510(k) premarket notification submitted by Masep Medical Science & Tech.Development (Shenzhen for the device "ROTATING GAMMA SYSTEM INFINI (INFINI)". The FDA issued a decision of Substantially Equivalent on March 22, 2011. 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
March 22, 2011
Date Received
September 3, 2010
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