(197 days)
The ViewMate System is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures and blood flow within the heart.
Not Found
This document is a 510(k) clearance letter from the FDA for the EP MedSystems ViewMate® System and ViewFlex™ Ultrasound Catheter. It declares the device substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on the regulatory clearance process, the intended use of the devices, and the associated regulations.
Therefore, I cannot provide the requested information from the given input.
§ 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.