Search Results
Found 1 results
510(k) Data Aggregation
(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 HDMIport. |
| 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: 518.4mmX324mmPortrait: 324X518.4mm | Landscape: 641mmX401mmPortrait: 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 | <2W | <2W |
| Dimensions (W x H x D) | W:Landscape: 556.8mmPortrait: 362.4 mmH:Landscape: 378 - 528mmPortrait: 572.4-625.2mmD: 227.6 mm | W:Landscape: 688mmPortrait: 446.8 mmH:Landscape: 466.4 - 616.4mmPortrait: 707.1-737.0mmD: 301.6 mm |
| NET Weight | 10.2 kg | 17 kg |
| Intended of use | Displaying and viewing of digital images for diagnosis by trained physiciansThis device can not use for a life support system.This device must not be use in digital mammography.This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment | Displaying and viewing of digital images for diagnosis by trained physiciansThis device can not use for a life support system.This device must not be use in digital mammography.This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment |
| Certifications & Standards | CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) submission for a display monitor, not an AI/algorithm-based diagnostic device requiring a test set of medical data (images, patient records, etc.). The "test" in this context refers to engineering and performance verification of the display hardware against technical specifications and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth typically refers to clinical diagnoses or pathology results for AI/algorithm validation. For a display monitor, "ground truth" would be the expected performance based on engineering specifications and calibration.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a display monitor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used
Not applicable in the clinical sense. The "ground truth" for evaluating this device would be its adherence to established technical specifications, industry standards (like DICOM Part 14), and safety regulations, verified through engineering tests and calibrations.
8. The sample size for the training set
Not applicable. This is a hardware device (display monitor), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Ask a specific question about this device
Page 1 of 1