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The DC-N2/DC-N2S Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid and testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult and pediatric), peripheral vascular and urology exams.

DC-N2/DC-N2S is asoftware controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PW, Color, Power , iScape, Smart 3D or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.5 MHz to 10.0 MHz.

The provided 510(k) summary for the DC-N2/DC-N2S Diagnostic Ultrasound System states "Clinical Studies: Not applicable. The subject of this submission, DC-N2/DC-N2S Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, it does not contain information regarding acceptance criteria, study design, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC comparative effectiveness studies, or standalone performance studies.

The submission focuses on demonstrating substantial equivalence through non-clinical tests and comparison with predicate devices, rather than through clinical performance data.

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