# K121663: Clarity

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Dec 5, 2012 after 183 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: 9 generations back to K954874 (1996). 86 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111332: Clarity Obp System, Elekta, Ltd. (2012) Summary page 1.
- K060906: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2006) Summary page 3.
- K080726: Calypso 4D Localization System, Calypso Medical Technologies, Inc. (2008) Summary page 1.

## Most influential descendants
- K141855: Clarity (2014), 0 descendants of its own

## Indications for use
Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft tissue anatomy to support radiation therapy simulation and treatment planning, and to guide patient positioning prior to the delivery of treatment. Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).

Source page: https://510kreport.com/device/K121663
Methodology: https://510kreport.com/methodology