# K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 30, 2014 after 58 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K850478 (1985). 6 ancestors in all.
64 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6, C.R. Bard, Inc. (2007) Summary page 6.

## Most influential descendants
- K152758: Venue 50 (2015), 55 descendants of its own
- K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (2016), 47 descendants of its own
- K161706: Vivid iq (2016), 46 descendants of its own
- K170714: Venue (2017), 35 descendants of its own
- K180599: Venue (2018), 28 descendants of its own

## Indications for use
The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed. Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Source page: https://510kreport.com/device/K142443
Methodology: https://510kreport.com/methodology