(15 days)
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system applied in ultrasound diagnostic examination of abdomen, obstetric, gynecology, cardiology and small parts etc. This device is intended to adult, pregnant woman, pediatrics.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal (B, M, Combined (B/M))
Abdominal (B, M, Combined (B/M))
Pediatric (B, M, Combined (B/M))
Small Organ (B, M, Combined (B/M))
Cardiac (B, M, Combined (B/M))
Transvaginal (B, M, Combined (B/M))
Peripheral Vascular (B, M, Combined (B/M))
Small organs include: thyroid, parathyroid, parotid, submaxillary gland, and Breast
Pediatric Intended Uses include: Cardiology, Abdomen, Peripheral Vasa
CHISON 8300 is a portable digital ultrasonic diagnostic B/W system.
Display mode: B, B/B, 4B, B/M, M. In the B or M mode, 128 frames of real-time image can be stored in Cine-memory.
The Standard configuration of the applicant device includes Main unit, probes, relative accessories.
There's no unique feature or technological characteristics for the applicant device.
Accessories include Video Printer and Trolley.
Applicant Probe types: C60613S (Convex, 3.5 MHz), L40617S (Liner Probe, 7.5 MHz), C12616S (Micro-convex, 6.0 MHz).
The provided document, a 510(k) Summary for the CHISON 8300 Digital Ultrasonic Diagnostic Imaging System, focuses on demonstrating the device's technical performance and safety rather than a clinical study involving human subjects or AI algorithms. Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or available in this specific document.
The "acceptance criteria" discussed in the document are primarily related to the measurement accuracy of the ultrasonic imaging system itself, using various probes.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Measurement | Unit | Range of Availability | Acceptance Criteria (Accuracy) | Reported Device Performance (Accuracy) |
|---|---|---|---|---|
| For CHISON-C60613S at 3.5MHz (Abdomen Probe) | ||||
| Axial Distance | mm | Full Screen (30~240mm) |
§ 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.