(13 days)
The CHISON 600M is intended for use with the following transducers: Convex Array C60, Linear Array L700, and Micro-convex Array C14. The clinical applications for the CHISON 600M with the Convex Array C60 transducer include Fetal, Abdominal, and Cardiac imaging in B, M, and Combined (B/M) modes. The clinical applications for the CHISON 600M with the Linear Array L700 transducer include Pediatric, Small Organ, Peripheral Vascular, and Musculo-skeletal imaging in B, M, and Combined (B/M) modes. Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast. The clinical application for the CHISON 600M with the Micro-convex Array C14 transducer is Transvaginal imaging in B, M, and Combined (B/M) modes.
Not Found
This document is a 510(k) premarket notification from the FDA for a diagnostic ultrasound system, the CHISON 600M, and its associated transducers. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
The core of the provided text is the FDA's decision letter for the CHISON 600M ultrasound system, indicating that the device is substantially equivalent to legally marketed predicate devices. This letter also outlines regulatory compliance requirements and specific conditions for marketing, such as submitting a post-clearance special report with acoustic output measurements.
The "Indications for Use" forms for the main device and its transducers (Convex Array C60, Linear Array L700, Micro-convex Array C14) list the clinical applications (e.g., Fetal, Abdominal, Cardiac, Small Organ, Peripheral Vascular) and modes of operation (e.g., B-mode, M-mode). The "N" in these tables indicates a "new indication" for that specific application and mode.
Therefore, I cannot provide the requested information because the document does not describe acceptance criteria for performance, nor does it detail a study that proves the device meets such criteria. It is a regulatory approval document based on substantial equivalence to existing devices, not a performance study report.
§ 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.