# K112841: Surface Beacon Transponders

- Pathway: 510(k) (Traditional)
- Applicant: Calypso Medical Technologies, Inc.
- Decided: Feb 16, 2012 after 140 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: 7 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)
- K060906: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2006) Summary page 1.
- K080726: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2008) Summary page 1.
- K102373: Calypso System with Dynamic Edge Gating, Calypso Medical Technologies, Inc. (2010) Summary page 1.
- K102024: RPM Respiratory Gating System, Varian Medical Systems (2010) Summary page 1.
- K092845: Respisens, Nomics (2010) Summary page 1.

## 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. The optional Dynamic Edge Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces. 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 prostate and the peri-prostatic tissue (i.e., prostatic bed) to align and monitor the treatment isocenter in real time during radiation therapy. Surface Beacon® transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

Source page: https://510kreport.com/device/K112841
Methodology: https://510kreport.com/methodology