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510(k) Data Aggregation
K Number
K091403Device Name
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
Manufacturer
ONCOLOGY TECH, LLC
Date Cleared
2009-07-29
(78 days)
Product Code
IXI
Regulation Number
892.5710Why did this record match?
Applicant Name (Manufacturer) :
ONCOLOGY TECH, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Oncology Tech precision milled brass/aluminum compensators with tungsten fillings in the compensator walls are used for modulation of beam intensity during radiation therapy.
Device Description
The Oncology Tech Mod1T Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy. Typically, a brass or aluminum round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions. The new design of Oncology Tech Mod1T compensators mills out the compensator brass or aluminum walls and adds a high density material. The higher density of the fill material in the compensator walls provides for more attenuation and less radiation transmission at the field edges.
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