(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 |
§ 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).