Calypso System ASM0195

GUDID 00850011006115

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.

VARIAN MEDICAL SYSTEMS, INC.

Implanted-marker patient positioning system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system Radiation therapy invasive marker lesion localization system

Primary Device ID	00850011006115
NIH Device Record Key	f2b8e722-ed79-4dd8-b8bb-b345f65b146e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Calypso System
Version Model Number	3
Catalog Number	ASM0195
Company DUNS	070809675
Company Name	VARIAN MEDICAL SYSTEMS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx
Phone	+1(888)827-4265
Email	xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011006115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123137

FDA Product Code

IYE	Accelerator, Linear, Medical

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-06-07

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