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.
Regulatory Flags# DUNS number 070809675 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810563022001 Mandrin for 200 mm length GM11010450 GM11010450 2024-02-16 10816389027296 Universal fixation button, radiopaque, pack of 100, non-sterile GM11003800 GM11003800 2016-09-23 00810563021967 Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin GM11014710 GM11014710 2024-02-16 00810563021974 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin GM11014720 GM11014720 2024-02-16 00810563021981 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin GM11014730 GM11014730 2024-02-16 00810563022018 Mandrin for 320 mm length GM11010470 GM11010470 2024-02-16 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin GM11014700 GM11014700 2024-02-16 00810563021998 Mandrin for 113 mm length GM11010390 GM11010390 2024-02-16 00816389022522 Mandrin for 200mm length Needle for Plastic Interstitial Needle GM11003270 GM11003270 2021-02-02 00816389022188 Flexible probe, 2.8 mm diameter x 320 mm GM11002280 GM11002280 2016-09-22 00816389022195 Mould probe, ø 1.8 diameter x 320 mm, with mandrin GM11002290 GM11002290 2016-09-19 00816389022478 Mandrin for 320mm length GM11003100 GM11003100 2016-09-23 00816389022553 Mandrin for 113mm length Needle GM11003340 GM11003340 2016-09-22 00816389022935 Catheter flap 200 mm x 290 mm x 10 mm, 40 channels GM11003910 GM11003910 2016-09-23 00816389024243 Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles GM11007560 GM11007560 2016-09-22 00816389024250 Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needles GM11007570 GM11007570 2016-09-18 00816389024267 Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles GM11007580 GM11007580 2016-09-19 00816389025615 Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin GM11010750 GM11010750 2016-09-22 00854393006084 Velocity 4.3 Velocity 4.3 2026-07-16 10816389027234 Cleaning Cap, dark blue (pack of 25) GM11010770 GM11010770 2016-09-22
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