# K141855: Clarity

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Oct 8, 2014 after 91 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: 10 generations back to K954874 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
4 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121663: Clarity, Elekta, Ltd. (2012) Summary page 4.

## Indications for use
Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy). When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the motion of the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring). When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the position of the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the tracked anatomy returns to a position within those limits (Exception Gating). Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta’s Response™ Gating Control System.

Source page: https://510kreport.com/device/K141855
Methodology: https://510kreport.com/methodology