(170 days)
The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology.
The SonoScape S8 ultrasound system is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. The SonoScape S8 System is configured as a portable model. The system is designed with the latest technology, using the same quality procedures as ultrasound systems, which have been available in the market for years. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
The provided document is a 510(k) Premarket Notification Summary for the SonoScape S8 Diagnostic Ultrasound System. It outlines the device description, intended use, and substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), or standalone algorithm performance.
The document primarily focuses on establishing the device's substantial equivalence to previously cleared devices (GE Voluson 730 Diagnostic Ultrasound System and Shenzhen Mindray DC-7 Ultrasound) based on its technological characteristics and intended uses.
Therefore, I cannot populate the requested tables and information as the necessary data is not present in the provided text. The document is a regulatory submission for market clearance, not a clinical performance study report.
§ 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.