(85 days)
The Diagnostic Ultrasound System Xario 100 Model TUS-X100 and TUS-X100S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, and musculo-skeletal (both conventional and superficial).
The Xario 100 Model TUS-X100 and TUS-X100S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 3 MHz to 10 MHz.
The provided text is a 510(k) Summary for a Toshiba Xario 100 diagnostic ultrasound system. This document outlines the general characteristics of the device and its intended use, but does not contain specific information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies.
The document states:
- "Design Control Activities including risk management following the ISO14971, verification/validation testing and Acoustic Output testing (UD3, 2004) were conducted through bench testing are included in this submission. This documentation includes testing which demonstrates that the requirements for the features have been met." (Section 15. SAFETY and 16. TESTING)
This statement indicates that verification and validation testing was performed, and requirements were met, but it does not provide the details of those tests, the acceptance criteria, or the reported performance. The 510(k) summary is a high-level overview and directs to the full submission for detailed documentation.
Therefore, I cannot extract the specific information you requested as it is not present in the provided text. The document confirms that testing was done to demonstrate that the device meets requirements, but the details of what those requirements are and the results of the tests are not included here.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.