# K102373: Calypso System with Dynamic Edge Gating

- Pathway: 510(k) (Special)
- Applicant: Calypso Medical Technologies, Inc.
- Decided: Sep 30, 2010 after 41 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: 6 generations back to K874787 (1987). 25 ancestors in all.
6 later devices descend from it; 3 cite it directly.
4 of 32 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.

## Most influential descendants
- K112768: Calypso Systems with Dynamic Edge Gating (2011), 4 descendants of its own
- 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 4D Localization 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 linear accelerator. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders. 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/K102373
Methodology: https://510kreport.com/methodology