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The E1 Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

The MFGD 1218 Medical Flat Panel Display is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

E1 is a display system for medical viewing. It consists of 3 components: MFGD 1218 is an 18" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

MFGD 1218 is an 18″ grayscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software that allows to optimize the display for DICOMcompliant viewing.

This document is a 510(k) premarket notification for the Barco E1 Medical Flat Panel Display System and MFGD 1218 Medical Flat Panel Display. It aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available within this document.

The document primarily focuses on:

• Device Identification: Trade names (E1 Medical Flat Panel Display System, MFGD 1218 Medical Flat Panel Display), common names (Display system, medical image workstation), and classification (21 CFR 892.2050 / Procode 90LLZ).
• Intended Use: "Displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography."
• Predicate Device: Nio 2MP Medical Flat Panel Display System (K042660) by Barco NV.
• Technological Characteristics: Describes the components (flat panel display, display controller board, NioWatch software), resolution (1280 x 1024 pixels), and grayscale (256 simultaneous shades of gray).
• Claim of Substantial Equivalence: States that the E1 system and MFGD 1218 are substantially equivalent to the predicate device in technical characteristics, general function, application, and intended use, and that any differences do not affect safety or efficacy.
• Safety Considerations: Notes that the device does not come into contact with the patient and does not control any life-sustaining devices.

In summary, this 510(k) submission is a regulatory filing for market clearance based on substantial equivalence, not a report of a performance study against specific acceptance criteria.

If such a study were required for this type of device, it would typically involve:

• Acceptance Criteria: Likely related to display performance metrics such as luminance, contrast ratio, uniformity, modulation transfer function (MTF), grayscale accuracy (DICOM Part 14 compliance), and resolution, compared to industry standards or the predicate device.
• Study Design: Often involves technical measurements using specialized equipment and potentially subjective evaluations by human readers for image quality.
• Ground Truth: For medical displays, ground truth would typically be established by comparing display output to known standards or a reference display, rather than pathology or patient outcomes.

However, based solely on the provided text, these details are not present.

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