Home GUDID 00850011006115
Calypso System
Primary DI 00850011006115
Brand Calypso System
Company VARIAN MEDICAL SYSTEMS, INC.
Model 3
Catalog number ASM0195
Device description The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system’s detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are placed on the patient’s skin surface or implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective, continuous measurement of the localization of the treatment target in 3 dimensions. The system operator uses this information for patient alignment and continuous target positioning (i.e., tracking) during radiation therapy treatment.
Published 2016-06-07
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name IYE Accelerator, Linear, Medical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYE Accelerator, Linear, Medical Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850011006115 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850011006115 00850011006115 850011006115 0850011006115
GMDN Terms# Term, Definition table Term Definition Implanted-marker patient positioning system An assembly of devices used primarily in radiation therapy applications, for radiation treatment planning, and during therapy treatment to align and monitor a patient's position relative to the isocenter of a radiation therapy system (e.g., a linear accelerator). It detects electromagnetic signals provided by passive implanted markers (transponders) which have been surgically implanted in or near the target site prior to the treatment. This enables accurate positioning and tracking of all information throughout the treatment phase and helps to ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams.
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