(43 days)
The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific output levels (track 1). Its function is to acquire ultrasound data in acoustical holography mode and display it on an LCD monitor.
The provided text is a 510(k) summary for the Altair Model DEI System, an acoustical holography imaging system. It describes the device, its intended use, and its technological comparison to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance testing sections of a 510(k) submission.
The document primarily focuses on regulatory compliance (safety standards, substantial equivalence to a predicate device) and a general description of the device's technology and intended uses.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The requested information (points 1-9) is not present in this document.
§ 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.