# K170570: Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Apr 6, 2018 after 403 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). 42 ancestors in all.
No later device cites it as a predicate yet.
4 of 43 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.
- K120796: Superdimension Nitinol/Gold Fiducial Marker, Superdimension, Inc. (2012) Summary page 5.

## 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. Anchored Beacon transponders are indicated for permanent implantation in small airways in the lung to align and/or monitor the internal position of targets that move with respiratory and other patient motion in real time during radiation therapy.

Source page: https://510kreport.com/device/K170570
Methodology: https://510kreport.com/methodology