# K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 14, 2015 after 97 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 8 generations back to K945773 (1995). 40 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132942: Site-Rite Vision II Ultrasound System, C.R. Bard, Inc. (2013) Summary page 7.
- K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology, C.R. Bard, Inc. (2014) Summary page 7.
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide, Bard Access Systems, Inc. (2012) Summary page 8.

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

## Recalls of this device
- Nov 4, 2019 · Class II · Z-0518-2020: The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running 

## 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 • 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: Imaging Applications — Exam Type (Adult and Pediatric) 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, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Source page: https://510kreport.com/device/K152554
Methodology: https://510kreport.com/methodology