(30 days)
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The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.
The provided text describes basic safety and operational characteristics of the Hitachi EUB-905 Ultrasound Electronic Scanner but does not contain information about acceptance criteria or a study demonstrating device performance as requested.
Therefore, I cannot populate the requested table or answer the specific questions regarding such a study. The document focuses on regulatory compliance regarding acoustic output and general electrical safety standards rather than clinical performance or efficacy.
To answer your questions, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of clinical evidence that details specific performance metrics and the methodology used to assess them.
§ 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.