# K112768: Calypso Systems with Dynamic Edge Gating

- Pathway: 510(k) (Traditional)
- Applicant: Calypso Medical Technologies, Inc.
- Decided: Nov 18, 2011 after 57 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, 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). 26 ancestors in all.
4 later devices descend from it; 1 cites it directly.
4 of 31 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 3.

## Most influential descendants
- K123137: Calypso System (2012), 3 descendants of its own
- K140823: Permanent Beacon Transponder/Soft Tissue Beacon Transponder (2014), 2 descendants of its own
- K170570: Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - Lung (2018), 0 descendants of its own
- K152761: Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) (2015), 0 descendants of its own

## Indications for use
The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and 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 EdgeTM 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. Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures. Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

Source page: https://510kreport.com/device/K112768
Methodology: https://510kreport.com/methodology