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510(k) Data Aggregation
K Number
K180595Device Name
SciMoCa
Manufacturer
Radialogica LLC
Date Cleared
2018-04-04
(29 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Radialogica LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses.
SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
Device Description
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
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