(74 days)
The Sonomark® accessory to linear diagnostic ultrasound transducers is indicated for diagnostic ultrasound procedures to mark anatomical features.
The Sonomark® accessory to Diagnostic Ultrasound Transducers is a skin-marking attachment.
The provided text is a 510(k) summary for the Sonomark® accessory. It does not contain information about acceptance criteria, device performance, or any study details that would prove the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (AiM Accuracy in Marking® System, K053463) and outlines the regulatory classification, intended use, and indications for use. It's a regulatory document for market clearance, not a technical report detailing performance studies.
Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document explicitly states: "Substantial equivalence has been demonstrated between the Sonomark® accessory, the AiM Accuracy in Marking® System (510(k) No.: K053463)." This suggests that the device's market clearance relied on proving similarity to an already approved device rather than presenting new performance study data against specific acceptance criteria.
§ 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.