(15 days)
The Power Vision 6000 is intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transesophageal, peripheral vascular, and musculo-skeletal (both conventional and superficial).
The PowerVision 6000 Ultrasound System is a mobile system. This system is a Track 3 device that employs a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 10 MHz.
The provided document is a 510(k) Summary for the Toshiba SSA-370A/PowerVision 6000 Ultrasound Imaging System. It outlines the device description, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria or specific studies proving the device meets acceptance criteria.
The tables within the document (pages 3-20) are "Diagnostic Ultrasound Indications For Use Form" for various transducers. These tables indicate whether certain clinical applications (e.g., Fetal, Abdominal, Cardiac) and modes of operation (e.g., B, M, PWD, Color Doppler) are "New indication (N)", "Previously Cleared by FDA (P)", or "Added under Appendix E (LTF)". This information describes the intended uses of the device and its transducers based on prior clearances or new submissions, but does not present performance data or acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification and claiming substantial equivalence to predicate devices rather than providing performance study details.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.