(61 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-Operative (Cardiac), Pediatric, Neonatal Cephalic, Cardiac (Adult), Cardiac (Pediatric), Trans-esophageal, Peripheral Vascular, Other (Intra-Luminal), and Other (Intra-Cardiac) Indications.
The Acuson Cypress Ultrasound System is an ultrasound imaging platform which is designed for use with a variety of internal and external transducers. The Acuson Cypress System is a compact and portable diagnostic ultrasound system with a fold-up keyboard, an integrated LCD type display, and interchangeable electronic transducers. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the Acuson Cypress Ultrasound System, focusing on substantial equivalence to predicate devices and listing intended uses for new transducers. It does not contain performance metrics, study designs, or details on how the device's accuracy or effectiveness was evaluated against specific criteria.
§ 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.