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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Small Organ (Specify): Thyroid, Testicles, Breast. Other (Specify): Real time 3D.

The SDU-1100 is a mobile diagnostic ultrasound system. This system has flat linear array, convex linear and sector probe with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, Pulsed Doppler mode, Real time 3D mode, Color mode, or in a combination of modes.

This document, K071291, is a 510(k) Summary for the SHIMADZU MEDICAL SYSTEMS SDU-1100 Ultrasound Imaging System. It describes the device, its intended use, and indicates which transducers support various clinical applications and operation modes. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, stating the device's substantial equivalence to a predicate device. It lists standards the device has been designed to meet (IEC 60601-1, AIUM NEMA UD2, AIUM 1998, AIUM NEMA UD3) for safety and acoustic output, but these are design standards, not performance acceptance criteria against a specific clinical study.

Therefore, I cannot provide the requested information from the provided text. The document is primarily an "Indications for Use" statement and regulatory approval letter, not a clinical study report.

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