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510(k) Data Aggregation
K Number
K042861Device Name
ODYSSEY
Manufacturer
PERMEDICS, INC.
Date Cleared
2005-01-12
(89 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PERMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
Device Description
The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.
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K Number
K993895Device Name
OPTIRAD
Manufacturer
PERMEDICS, INC.
Date Cleared
2000-06-02
(199 days)
Product Code
MUJ
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
PERMEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OptiRad software is to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
Device Description
The OptiRad 3D-radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). Input is user controlled. This treatment planning system does not provide direct or indirect control over any treatment delivery device or system in any form. The OptiRad software application is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, dosimetrist, or radiation treatment planner.
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