# K132942: Site-Rite Vision II Ultrasound System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 17, 2013 after 28 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945773 (1995). 30 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100402: Site-Rite Vision Ultrasound System, Bard Access Systems, Inc. (2010) Summary page 2.

## Most influential descendants
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own
- K251673: X9 Ultrasound System (2025), 0 descendants of its own
- K243479: EchoGuide (Version 1) (2025), 0 descendants of its own

## Indications for use
The Site-Rite Vision* 11Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include: * Fetal * Abdominal * Intra-operative (semi-critical†) * Pediatric * Peripheral Vessel * Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) * Musculo-skeletal (conventional and Superficial) * Cardiac (adult and pediatric) Typical examinations performed using the Site-Rite Vision* 11Ultrasound System include: Imaging Applications — Exam Type (adult & pediatric) Vascular: Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs Vascular Access: Guidance for a PICC, CVC, dialysis catheter, port, PICC, and arterial-line placement, and peripheral vein and artery access Abdominal: Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures Interventional and Intraoperative: Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi-critical†) Superficial: Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures † Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.

Source page: https://510kreport.com/device/K132942
Methodology: https://510kreport.com/methodology