# K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

- Pathway: 510(k) (Traditional)
- Applicant: C. R. Bard
- Decided: Oct 24, 2018 after 62 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: 9 generations back to K945773 (1995). 41 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology, C.R. Bard, Inc. (2015) Summary page 8.

## Most influential descendants
- 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
- K240146: BD Prevue™ II Peripheral Vascular Access System (2024), 0 descendants of its own
- K231283: SiteRite™ 9 Ultrasound System (2023), 0 descendants of its own

## Indications for use
The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. 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) Typical examinations performed using the Site~Rite® 8 Ultrasound System include: Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian) 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 (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.

Source page: https://510kreport.com/device/K182281
Methodology: https://510kreport.com/methodology