(154 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
IMEX StethoDop™ (Doppler Ultrasound Device)
This document is a marketing clearance letter from the FDA for the IMEX StethoDop™ (Doppler Ultrasound Device) with a 5 MHz transducer, dated February 5, 1998. It establishes substantial equivalence to a predicate device and allows the manufacturer to market the device.
However, the provided text does not contain any information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or how ground truth was established for training sets.
The document primarily focuses on regulatory approval, substantial equivalence, manufacturing practices, labeling regulations, and post-clearance reporting requirements related to acoustic output measurements. The "Indications for Use Form" in Appendix F lists various clinical applications and modes of operation for ultrasound systems but does not provide performance metrics or acceptance criteria for the IMEX StethoDop™.
Therefore, based solely on the provided text, I cannot complete the requested tables and information.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.