(51 days)
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.
Therefore, I cannot provide the requested information based on the input text.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.