# K152761: Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Nov 25, 2015 after 62 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K874787 (1987). 32 ancestors in all.
No later device cites it as a predicate yet.
4 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140823: Permanent Beacon Transponder/Soft Tissue Beacon Transponder, Varian Medical Systems, Inc. (2014) Summary page 4.

## Indications for use
The Calypso system is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso system provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders. Implanted Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures. Permanent Beacon transponders are indicated for implantation in the body, specifically in the prostate and peri-prostate tissue (i.e. prostatic bed), and in soft tissue to align and monitor the treatment isocenter in real time during radiation therapy.

Source page: https://510kreport.com/device/K152761
Methodology: https://510kreport.com/methodology