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510(k) Data Aggregation
(30 days)
The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
The provided document describes a 510(k) submission for a 3MP Color LCD Display (C32SP+/C32S+) for medical viewing. The submission focuses on demonstrating substantial equivalence to a predicate device, the BARCO Nio Color 3MP LED.
Acceptance Criteria and Device Performance:
The "acceptance criteria" in this context are not explicitly stated as quantitative thresholds for a medical device's performance in a diagnostic study. Instead, for this type of device (a medical display), "acceptance criteria" are typically related to meeting established technical and safety standards, and demonstrating performance comparable to a cleared predicate device.
The document provides a comparison table (Table 2 General Comparison) that serves as the basis for demonstrating substantial equivalence. The "reported device performance" refers to the specifications of the proposed device.
| Comparison Item | Acceptance Criteria (based on predicate) | Reported Device Performance (Proposed Device C32SP+/C32S+) |
|---|---|---|
| Panel Size and Type | 21.3", TFT LCD display | 21.3", TFT LCD display |
| Pixel Pitch | 0.2115 mm | 0.2115 mm |
| Available Cabinet Colors | Black | Black |
| Native Resolutions | 2048 x 1536 | 2048 x 1536 |
| Brightness | 1700 cd/m² | 1700 cd/m² |
| Contrast Ratio | 1300:1 | 1400:1 |
| Network Interface | USB(1 Up, 2 Downstream) | USB(1 Up, 2 Downstream) |
| Active Display Size | 433.2mm x 324.9mm | 433.152mm x 324.864mm |
| Dimensions (without Stand) | 375mm x 488mm x 84mm | 369.0mm (W) x 482.6mm (H) x 63.6mm (D) |
| Operating Temperature | 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temperature | -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Relative Humidity | 8% ~ 80% (non-condensing) | 15% ~ 85% |
| Transport/Storage Relative Humidity | 5% ~ 95% | 10% ~ 90% |
| Power Capacity |
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