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

• 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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