(18 days)
The MD211G3 gray scale 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.
MD211G3 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, MD211G3 is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Here's an analysis of the acceptance criteria and study information for the NEC MD211G3 medical display, based on the provided text:
Acceptance Criteria and Device Performance (Table)
The device, MD211G3, is a medical LCD monitor. The primary "acceptance criteria" discussed are its performance specifications, which are benchmarked against those of its predicate device, the L218TL. The study aims to demonstrate substantial equivalence by meeting these comparable specifications.
| Acceptance Criteria (Predicate: L218TL) | Reported Device Performance (MD211G3) |
|---|---|
| Panel Size and Type: 21.3" TFT Monochrome LCD Monitor | 21.3" TFT Monochrome LCD Monitor |
| Pixel Pitch: 0.212 mm x 0.212mm | 0.212 mm x 0.212mm |
| Display Monochromes: 10-bit (1024 grey tones) with 3061 total colors | 10-bit (1024 grey tones) with 3061 total colors |
| Viewing Angles (°) : H:176, V:176 | H:176, V:176 |
| Scanning Frequency (H, V): 31.5-95.4kHz, 30-85 Hz | 31.5-95.4kHz, 30-85 Hz |
| Native Resolutions: 2048X1536 | 2048X1536 |
| Brightness: 400 cd/m² calibrated, 1450 cd/m² Max. | 400 cd/m² calibrated, 1450 cd/m² Max. |
| Contrast Ratio: 900 : 1 (typical) | 900 : 1 (typical) |
| DOT Clock: 162 MHz | 188 MHz |
| Input Signals: Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital) | Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital) |
| Input Terminals: DVI-D, D-sub | DVI-D, D-sub |
| USB (option) / Standard | No |
| Active Display Size (H x V): Landscape: 433mmX325mm; Portrait: 325X433mm | Landscape: 433mmX325mm; Portrait: 325X433mm |
| Viewable Image Size: 540 mm (diagonal) | 540 mm (diagonal) |
| Luminance Calibration: Software | Software |
| Default Gamma: 1.8,2.0,2.2 DICOM part 14 + off, user | 1.8,2.0,2.2 DICOM part 14 user |
| Power: AC100-240V, 50/60Hz | AC100-240V, 50-60Hz |
| Power Consumption: 98W (Max) | 100W (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).