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510(k) Data Aggregation
K Number
K031975Device Name
IMSURE
Manufacturer
PRODIGM, INC.
Date Cleared
2003-08-29
(64 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PRODIGM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMSure is indicated for use as a quality assurance tool to verify IMRT treatment plans developed on any radiation therapy treatment planning system with the appropriate transfer format. IMSure will also perform primary monitor unit calculations from measured physics data for plans of known geometry.
Device Description
IMSure is a software program designed to provide a second, independent verification of IMRT plans created on primary radiation therapy treatment planning systems. After independently calculating the imported plan and fluence maps, IMSure compares results with the imported plan and maps, and calculates the differences. This second check provides an effective QA tool for verification of the original IMRT treatment plan. IMSure also may be used to compute primary monitor unit calculations for single and multiple beams with open, blocked, and wedged fields.
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