# K060906: Calypso 4D Localization System

- Pathway: 510(k) (Traditional)
- Applicant: Calypso Medical Technologies, Inc.
- Decided: Jul 28, 2006 after 116 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: 4 generations back to K911783 (1994). 13 ancestors in all.
11 later devices descend from it; 8 cite it directly.
4 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983660: Exactrac (Brainlab Patient Positioning System), Brainlab, Inc. (1999) Summary page 1.
- K003285: Exac Trac 2.0 (Novalis Body Module), Brainlab AG (2001) Summary page 1.
- K040585: Exactrac 4.0 and Exactrac X-Ray 6D, Brainlab AG (2004) Summary page 1.
- K960330: Instatrak, Visualization Technology, Inc. (1996) Summary page 1.
- K983529: Instatrak 3000, Visualization Technology, Inc. (1998) Summary page 1.
- K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000, Visualization Technology, Inc. (2000) Summary page 1.
- K012575: Prefernce Imrt Treatment Planning Module, Northwest Medical Physics Equipment, Inc. (2002) Summary page 1.

## Most influential descendants
- K080726: Calypso 4D Localization System (2008), 9 descendants of its own
- K102373: Calypso System with Dynamic Edge Gating (2010), 6 descendants of its own
- 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

## 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 permanent implantation in the prostate only.

Source page: https://510kreport.com/device/K060906
Methodology: https://510kreport.com/methodology