# K032135: Site-Rite IV Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Dymax Corp
- Decided: Jul 21, 2003 after 10 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: 2 generations back to K850478 (1985). 3 ancestors in all.
140 later devices descend from it; 1 cites it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993624: Site-Rite 3 Ultrasound System, Dymax Corp (1999) Summary page 1.
- K862127: Dymax Personal Scanner, Dymax Corp (1986) Summary page 1.

## Most influential descendants
- K052517: Site-Rite 5 Ultrasound System (2005), 139 descendants of its own
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6 (2007), 136 descendants of its own
- K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology (2014), 64 descendants of its own
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker (2009), 61 descendants of its own
- K152758: Venue 50 (2015), 55 descendants of its own

## Indications for use
The Site-Rite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously. The Site-Rite IV Ultrasound System is not intended for ophthalmic applications.

Source page: https://510kreport.com/device/K032135
Methodology: https://510kreport.com/methodology