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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

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