(223 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Neonatal Cephalic, Intravascular, Peripheral Vascular, Adult Cephalic
SYSTEM LEGEND TC 22
This document is an FDA 510(k) clearance letter dated June 29, 2000, for the Nicolet EME Legend TC22 ultrasound system and associated transducers. It outlines the intended uses of the device and confirms its substantial equivalence to legally marketed predicate devices.
The document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established. This type of detailed performance data is typically found in the 510(k) summary or premarket notification submission itself, not in the clearance letter.
The tables presented in the document are "Diagnostic Ultrasound Indications for Use Forms," which specify the clinical applications and modes of operation for which each transducer is cleared. They are not performance reports.
Therefore, I cannot provide the requested information from the provided text.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue 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.