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JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

JUSHA-C620G LCD/JUSHA-C620/C620G/C620 LCD Monitor is the display system with the high resolution (3280*2048), high luminance (500 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C620G LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. In addition, JUSHA-C620G has ambient brightness adapting, 3D LUT color calibration, real-time DICOM automatic calibration, Full-screen brightness equalization, presence induction, focusview and text mode function, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:

• 30" Color TFT LCD Panel
• C44&C62 Mother board/FR-6/V1.2
• JUSHA-C620G LCD Monitor software
• Power Adapter
• Data Cable.
  The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
  IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

The provided text is a 510(k) summary for the JUSHA-C620G LCD Monitor. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. For such devices, the focus is on non-clinical testing and comparison to a predicate, rather than extensive clinical studies or AI algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment (which are typical for AI/ML medical devices) is not applicable to this specific submission. This device is a medical display monitor, not an AI diagnostic algorithm.

Specifically, the document states:

• "Summary of Clinical Tests: The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." (Page 4, under "Determination of Substantial Equivalence")

This indicates that the manufacturer did not conduct a clinical study to prove the device's performance against specific acceptance criteria in a real-world clinical setting, as would be expected for an AI software. Instead, substantial equivalence was demonstrated through non-clinical tests (meeting safety and performance standards like IEC 60601-1 and IEC 60601-1-2) and a comparison table of characteristics with the predicate device (JUSHA-C61; K141679).

Therefore, I cannot provide the requested details because they are not part of the information required or presented in this 510(k) submission for a medical display monitor.

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