# K993624: Site-Rite 3 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Dymax Corp
- Decided: Nov 10, 1999 after 15 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: 1 generation back to K850478 (1985). 2 ancestors in all.
275 later devices descend from it; 5 cite it directly.
2 of 278 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K862127: Dymax Personal Scanner, Dymax Corp (1986) Summary page 1.
- K850478: PLUS 1, Dymax Corp (1985) Summary page 1.

## Most influential descendants
- K032135: Site-Rite IV Ultrasound System (2003), 140 descendants of its own
- 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
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries) (2002), 124 descendants of its own
- K090505: Speq Ultrasound System (2009), 107 descendants of its own

## Indications for use
The Site~Rite 3 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 3 is not intended for opthalmic applications.

Source page: https://510kreport.com/device/K993624
Methodology: https://510kreport.com/methodology