# K231283: SiteRite™ 9 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
- Decided: Sep 11, 2023 after 131 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: 10 generations back to K945773 (1995). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech, C. R. Bard (2018) Summary page 5.

## Indications for use
The SiteRiteTM 9 Ultrasound System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include: * Pediatric * Peripheral Vessel and Vascular Access * Small Organ (breast, thyroid, parathyroid, testicles) * Musculo-skeletal (conventional and superficial) * Cardiac (adult and pediatric) The SiteRiteTM 9 Ultrasound System is indicated for Vascular, Vascular Access, Interventional, and Superficial Imaging Applications. Typical examinations performed using the SiteRiteTM 9 Ultrasound System include: Imaging Applications — Exam Type (Adult and Pediatric) Vascular: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access. Interventional: Guidance for biopsy and drainage. Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures. The SiteRiteTM 9 Ultrasound System transducer operates using B mode imaging.

Source page: https://510kreport.com/device/K231283
Methodology: https://510kreport.com/methodology