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MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME77/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal cephalic, transrectal, trans-vaginal, musculo-skeletal(conventional), musculo- skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , transesoph(Cardiac) exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, i iScape, TDI, color M, Smart 3D, Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver) mode.

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

The provided text is a 510(k) summary for a diagnostic ultrasound system (MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System). This document is primarily focused on demonstrating substantial equivalence to a predicate device based on technical characteristics, intended use, and non-clinical testing.

Based on the provided document, the device did not undergo clinical studies to prove its performance against acceptance criteria in the manner requested (i.e., a study comparing device performance against a defined ground truth, potentially involving human readers, and meeting specific statistical thresholds).

The document explicitly states:

"8. Clinical Studies
Not applicable. The subject of this submission, MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document. The submission relies on non-clinical tests to demonstrate substantial equivalence to established predicate devices.

The acceptance criteria for this type of submission are primarily met through:

• Comparison of Intended Use: Showing that the new device's intended uses are comparable to (or covered by) legally marketed predicate devices.
• Comparison of Technological Characteristics: Demonstrating that the fundamental technology (e.g., imaging modes, physical principles) is substantially equivalent to predicate devices.
• Non-Clinical Performance Testing: Proving the device meets recognized safety and performance standards (e.g., acoustic output, electrical safety, electromagnetic compatibility, biocompatibility, software lifecycle, risk management).

In summary, the document does not contain the information required to populate the requested table or answer the specific questions about clinical study performance, as no such clinical study was required or performed for this 510(k) submission.

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