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The PET 512MC is a multiplane transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

The PET-512MC is a multiplane transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound Systems. It conforms to Track 3 when connected to the compatible ultrasound diagnostic systems. The scanning type of this transducer is a phased array with a frequency of 5MHz.

The provided 510(k) summary for the Toshiba PET-512MC Transesophageal Transducer does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a declaration of substantial equivalence to predicate devices, focusing on technical specifications, intended use, and compliance with general regulatory standards for medical devices and ultrasound systems (IEC standards, AIUM-NEMA standards). It does not present results from performance studies, clinical trials, or any data analysis that would include acceptance criteria and reported device performance.

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