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Ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Trans-esophageal, Transrectal, Transvaginal, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.

The ANTARES system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

The provided text is a 510(k) summary for the ACUSON ANTARES™ Diagnostic Ultrasound System. It describes the device, its intended uses, and compares it to predicate devices. However, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document focuses on regulatory compliance, specifically demonstrating substantial equivalence to previously cleared devices. It lists safety standards the system is designed to meet (UL, CSA, NEMA, EN, IEC, ISO) and states that its acoustic output is in accordance with the ALARA principle.

The tables provided describe the intended uses for various transducers with the ACUSON Antares ultrasound system, detailing which modes of operation (A-mode, B-mode, M-mode, Pulsed Wave Doppler, Continuous Wave Doppler, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other) are cleared for specific clinical applications (e.g., Fetal, Abdominal, Cardiac, Small Organ). The "P" indicates that these applications were "previously cleared by FDA" for predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating performance, as it is not present in the provided text.

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