(27 days)
Software used in a device that saves, enlarges, reduces, views as well as analyzes, transfers and prints medical images. (excluding fluoroscopic, angiographic, and mammographic applications.)
ASHK100G is digital radiography operating console software. ASHK100G provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, ASHK100G acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
This document, a 510(k) premarket notification for the ASHK100G device, indicates that clinical testing was not applicable for this submission. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Rayence Co., Ltd.'s XmaruView V1, Xmaru Chiroview, Xmaru Podview, and Xmaru PACS) based on technological characteristics and indications for use, rather than clinical performance data.
Specifically, page 8, section 9, explicitly states: "Clinical Test Summary [21 CFR 807.92(b)(2)] This section is not applicable."
As a result, I cannot provide the requested details about acceptance criteria and study findings.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).