(72 days)
The MD302C4 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.
MD302C4 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
This document describes a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD302C4). The submission aims to demonstrate substantial equivalence to a predicate device (MD242C2) rather than proving the device meets specific acceptance criteria through a clinical study. As such, most of the requested information (sample size, data provenance, expert qualification, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this type of submission.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in the typical sense of a clinical study with performance metrics. Instead, it compares the technical specifications and intended use of the new device (MD302C4) to a predicate device (MD242C2) to establish substantial equivalence. The "acceptance criteria" here are implicitly that the new device's performance characteristics are comparable or superior to the predicate device, or fall within acceptable ranges for diagnostic display devices.
| Items | Predicate Device (MD242C2) | Reported Device Performance (MD302C4) |
|---|---|---|
| Panel Size and Type | 24.1" TFT Color LCD Monitor | 29.8" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270mm | 0.251mm x 0.251mm |
| Display Color | 1,073,741,824 | 16,777,216 |
| Viewing Angles (°) | H:178, V:178 | H:178, V:178 |
| Scanning Frequency | ||
| (H, V) | 31.5-93.8, 118.4kHz, 50-85 Hz | 31.5-98.7 kHz, 50-85 Hz |
| Native Resolutions | 1920X1200 | 2560X1600 |
| Brightness | 180 cd/m² calibrated, | |
| 350 cd/m² Max. | 180 cd/m² calibrated, | |
| 340 cd/m² Max. | ||
| Contrast Ratio | 1000 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 202.5 MHz (Max) (Analog) | |
| 162 MHz (Max) (Digital) | 269 MHz (Max) | |
| Input Signals | Three connectors: one DVI port, | |
| one Display port, one HDMI port. | Three connectors: one DVI port, | |
| one Display port, one HDMI | ||
| port. | ||
| Input Terminals | DVI-D, Display port, HDMI port | DVI-D, Display port, HDMI port |
| USB (option) / Standard | No | No |
| Active Display Size (H x V) | Landscape: 518.4mmX324mm | |
| Portrait: 324X518.4mm | Landscape: 641mmX401mm | |
| Portrait: 401X641mm | ||
| Viewable Image Size | 540 mm (diagonal) | 756 mm |
| Luminance Calibration | Software | Software |
| Default Gamma | 1.8,2.0,2.2 DICOM part 14 | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 38.4W (Max) | 87W (Max) |
| Power Save Mode |
§ 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).