# K100402: Site-Rite Vision Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Mar 5, 2010 after 17 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945773 (1995). 29 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 40 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 1.
- K071134: Sonosite Maxx Series Diagnostic Ultrasound System, Sonosite,Inc. (2007) Summary page 1.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.
- K043452: Titan High Resolution Ultrasound System and Sonosite Ultrasound System, Sonosite,Inc. (2004) Summary page 1.
- K033367: Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464, Sonosite,Inc. (2003) Summary page 1.
- K030949: Titan High Resolution Ultrasound System, Sonosite,Inc. (2003) Summary page 1.

## Most influential descendants
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K132942: Site-Rite Vision II Ultrasound System (2013), 7 descendants of its own
- 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

## Recalls of this device
- Jun 21, 2011 · Not classified · Z-2782-2011: Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.

## Indications for use
The Site~Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intraoperative (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™ Ultrasound 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 PICC, CVC, dialysis catheter, port, PIV, 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/K100402
Methodology: https://510kreport.com/methodology