(21 days)
Diagnostic Ultrasound
Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular
Model 1.0 Diagnostic Ultrasound System
The provided document is a 510(k) clearance letter from the FDA for a diagnostic ultrasound system, Model 1.0, and its transducers (214U and 218PA). It primarily focuses on the regulatory clearance for the device's intended uses, comparing it to legally marketed predicate devices.
This document does NOT contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert ground truth, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.
The "Indications for Use Form" tables (pages 2-4) list various clinical applications and the modes of operation available for the Model 1.0 system and its transducers. "P" indicates a previously cleared indication, and "N" indicates a new indication (for the system or transducer). "E" means "Added under Appendix E," suggesting an expanded indication.
Therefore, I cannot provide the requested information. The document serves as an FDA clearance letter and the associated intended use statements, not a detailed technical report on a study proving device performance against acceptance 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.