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The Site-Rite Prevue Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:

• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel

The Site-Rite Prevue+ Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:

• Adult Cephalic
• Neonatal Cephalic
• Pediatric
• Peripheral Vessel

The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue® Ultrasound System. The device is intended for use with pediatrics and adults.

The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

The Site~Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, simple user interface, and various calculations. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide/gel cap kits, etc. The system includes USB support for storage devices with no external power connections (eg., USB flash drive).

The Site~Rite Prevue® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size, and simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (e.g., USB flash drive).

The Site~Rite Prevue+® Ultrasound System is a portable device that features real-time 2D ultrasound imaging. Additional features include compact size and a simple user interface. The system may incorporate various accessories, including an upright stand, A/C adapter, needle guide, etc. The system includes USB support for storage devices with no external power connections (eq., USB flash drive).

The provided text is a 510(k) Summary for the Site-Rite Prevue® Ultrasound System and the Site-Rite Prevue+® Ultrasound System. It details aspects of the device's design, indications for use, and a comparison to a predicate device.

However, the document does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets the acceptance criteria. This type of detailed study information, including specific performance metrics, sample sizes for test/training sets, expert information, and adjudication methods, is typically found in the full 510(k) submission, not in the summary document. The summary only broadly states that "Verification and validation activities were designed and performed to demonstrate that the subject SiteRite Prevue® Ultrasound System and the SiteRite Prevue+® Ultrasound System met predetermined performance specifications" and "The subject devices met all pre-determined acceptance criteria."

Therefore, I cannot provide the requested table and detailed study information based on the provided text. The document refers to compliance with various medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, NEMA UD 2-2004), which outline general requirements for safety and performance, but it does not specify device-specific acceptance criteria or the study results that demonstrate these criteria were met.

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