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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

EUB-6500 Diagnostic Ultrasound Scanner

The provided text outlines the intended use and modes of operation for various transducers of the Hitachi EUB-6500 Diagnostic Ultrasound Scanner. It does not contain information about acceptance criteria for a specific outcome, nor does it describe a study proving the device meets particular performance metrics.

Instead, this document appears to be part of a 510(k) premarket notification to the FDA, detailing the intended uses for different transducers associated with the EUB-6500 system. The "E" and "P" notations in the tables indicate whether an intended clinical application and mode of operation was "Added under Appendix E" (meaning new for this submission) or "Previously Cleared" (referring to a previous submission, K013723).

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory submission outlining intended uses, not a performance study.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only), Specific (Tracks I & III)
Mode of Operation: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Doppler, Combined (Spec.), Other (Spec.)
Other (Spec.) includes Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Specific clinical applications vary by transducer.

The Hitachi EUB-6500 Diagnostic Ultrasound Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

The provided text does not contain information about acceptance criteria or specific studies to prove device performance for the Hitachi EUB-6500 Diagnostic Ultrasound Scanner.

The document is a 510(k) premarket notification letter from the FDA, and it focuses on:

• Device Description: A general overview of the Hitachi EUB-6500's capabilities and operating modes.
• Safety Compliance: Statements regarding adherence to NEMA and IEC standards for acoustic output and general electrical safety.
• Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use Tables: Detailed tables that outline the specific clinical applications and modes of operation for various transducers used with the EUB-6500. For each application, "N" indicates a new indication, and subscripts provide additional context (e.g., "Na" for abdominal imaging including biopsy guidance).
• Post-Clearance Special Report Requirement: A condition for marketing requiring submission of acoustic output measurements from production line devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated studies, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for the Hitachi EUB-6500 based on the provided text.

This document is primarily a regulatory communication confirming marketing clearance based on substantial equivalence, not a performance study report.

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