Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT N…
FDA 510(k)Class II (US FDA 510(k))
by C. R. Bard
Identifiers
- 510(k) Number
- K182281 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Site-Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech is a medical imaging device classified as an Ultrasound Imaging System (FDA Product Code: IYO). It combines real-time ultrasound visualization with advanced needle tracking technology to assist in precise procedural guidance, particularly for vascular access and interventional procedures. The system integrates a linear probe for imaging and specialized needle tracking features to enhance accuracy during needle placement. Its primary function is to provide clinicians with enhanced visualization of anatomical structures and needle trajectory, reducing procedural risks and improving outcomes.
This device is intended for use in clinical settings such as radiology departments, operating rooms, or interventional suites. It is supplied as a reusable system, requiring proper maintenance and calibration per manufacturer guidelines. The system includes linear probes (e.g., 32mm and 20mm) and is designed for MRI-safe environments when used as specified. Storage and handling must comply with regulatory and manufacturer recommendations to ensure optimal performance and sterility. The Site-Rite 8 holds FDA 510(k) clearance under the Radiology Advisory Committee, with a decision code of SESE (Substantially Equivalent) and K-number K182281.
Frequently asked questions
What is the primary purpose of the Site-Rite 8 Ultrasound System with Cue Needle Tracking?
The Site-Rite 8 Ultrasound System is designed to assist clinicians in performing precise procedural guidance, particularly for vascular access and interventional procedures. It integrates real-time ultrasound visualization with advanced needle tracking technology (Cue Needle Tracking System and Pinpoint GT Needle Tech) to enhance accuracy during needle placement. This reduces procedural risks by providing clear visualization of anatomical structures and needle trajectory, ultimately improving clinical outcomes.
Is the Site-Rite 8 Ultrasound System reusable or single-use?
The Site-Rite 8 Ultrasound System is a reusable device. It requires proper maintenance, calibration, and adherence to manufacturer guidelines to ensure optimal performance and reliability. The system components, such as linear probes (e.g., 32mm and 20mm), are part of the reusable setup and must be handled according to regulatory and manufacturer recommendations.
What types of probes are included with the Site-Rite 8 Ultrasound System?
The Site-Rite 8 Ultrasound System includes linear probes, specifically models like the 32mm and 20mm. These probes are designed for high-resolution imaging, which is essential for precise needle guidance during procedures. The choice of probe may depend on the clinical application and anatomical area being visualized.
Can the Site-Rite 8 Ultrasound System be used in MRI-safe environments?
Yes, the Site-Rite 8 Ultrasound System is designed for use in MRI-safe environments when operated as specified by the manufacturer. This ensures compatibility with magnetic resonance imaging facilities, reducing the risk of interference or safety hazards during combined procedures. Always follow manufacturer guidelines and regulatory standards for safe operation.
What regulatory clearance does the Site-Rite 8 Ultrasound System hold?
The Site-Rite 8 Ultrasound System holds FDA 510(k) clearance under the Radiology Advisory Committee. It was determined to be substantially equivalent (SESE) to a predicate device, with a clearance decision date of October 24, 2018, and a K-number of K182281. This clearance allows the device to be marketed in the U.S. for its intended use in clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Site-Rite™ 8 Ultrasound System - BD, BARD SITE-RITE 8 INSTRUCTIONS FOR USE MANUAL Pdf Download, Bard Site-Rite 8 - User Manual, Bard Site-Rite 8 - 1 Overview; Site~Rite 8 Ultrasound System Device ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182281 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard
Sources (1)
- FDA 510(k) K182281 24 fields · synced Oct 1, 2026