# K111332: Clarity Obp System

- Pathway: 510(k) (Traditional)
- Applicant: Elekta, Ltd.
- Decided: Jan 30, 2012 after 264 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: 8 generations back to K954874 (1996). 62 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041937: Restitu, Resonant Medical, Inc. (2004) Summary page 1.
- K083591: Ikoengelo, Version 2, Ikoetech, LLC (2008) Summary page 1.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 1.

## Most influential descendants
- K121663: Clarity (2012), 1 descendant of its own
- K141855: Clarity (2014), 0 descendants of its own

## Indications for use
The Clarity'" OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

Source page: https://510kreport.com/device/K111332
Methodology: https://510kreport.com/methodology