# K150529: Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 30, 2015 after 28 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: 8 generations back to K945773 (1995). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide, Bard Access Systems, Inc. (2012) Summary page 7.

## Indications for use
The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: • Adult Cephalic • Neonatal Cephalic • Pediatric • Peripheral Vessel The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: • Adult Cephalic • Neonatal Cephalic • Pediatric • Peripheral Vessel The gel cap is intended for use as an ultrasound coupling medium for use with the Site~Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults. The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

Source page: https://510kreport.com/device/K150529
Methodology: https://510kreport.com/methodology