(29 days)
The Ultrasound System SONIMAGE HS1 and its transducers are products designed to collect ultrasonic image data of the human body for diagnostic purposes. The system employs the ultrasonic pulse-echo method to visualize the anatomic structures, characteristics, and dynamics of the human body, and using an image display, Doppler display and/or Doppler sound, offers a procedure applied to the human body for medical diagnosis or examination. The range of intended clinical applications is same as other conventional ultrasound imaging systems for general purpose, such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and Cardiac.
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This document is a 510(k) clearance letter from the FDA for a new ultrasound system, the KONICA MINOLTA SONIMAGE HS1. It lists the device's indications for use and associated transducers and operating modes. No information about acceptance criteria or a study that proves the device meets specific acceptance criteria for AI performance is present in the provided text.
The document describes the intended use of the ultrasound system for general diagnostic purposes, including various clinical applications such as small parts, abdomen, obstetrics, gynecology, musculoskeletal (soft tissue), peripheral vascular, and cardiac imaging, using different operational modes like B-mode, M-mode, Pulsed Wave Doppler (PWD), Continuous Wave Doppler (CWD), and Color Doppler.
Therefore, the requested information cannot be extracted from the given text as it does not pertain to AI performance or related studies.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.