(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.
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Hitachi EUB-905 Ultrasound Electronic Scanner June 29, 1996
Attachment 11 Page 1
ATTACHMENT 11
SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-905 Ultrasound Electronic Scanner
Device Description
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.
Safety
With respect to limits on acoustic outputs, the Hitachi EUB-905 Ultrasound Electronic Scanner comply with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance as a Track1 ultrasound system.
With regard to general safety, the Hitachi EUB-905 Ultrasound Electronic Scanner is designed to comply with the international standards IEC 601-1 (1988) Medical Electrical Equipment, Part1, General Requirements for Safety.
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