(24 days)
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
The document describes a 510(k) premarket notification for several Hisense LCD monitor models (HMD2G21, HMD3G21, HMD5G21). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards, and by demonstrating performance comparable to or better than the predicate devices. The study detailed below focuses on comparing the Hisense monitors' specifications to those of their respective predicate devices.
Here's a consolidated table comparing the proposed Hisense devices (HMD2G21, HMD3G21, HMD5G21) with their identified predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) based on the provided "General Comparison" tables.
| Feature | Acceptance Criteria (Predicate Device Performance) | Hisense HMD2G21 Performance | Hisense HMD3G21 Performance | Hisense HMD5G21 Performance |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography for 2MP/3MP; including digital mammography for 5MP) for review and analysis by trained medical practitioners. | Same as predicate | Same as predicate | Same as predicate |
| Panel Size & Type | 21.3", TFT LCD display (2MP, 5MP); 21.3", TFT LCD display (3MP) | 21.3", TFT LCD display | 21.2", IPS-NEO, antiglare | 21.3", IPS-NEO, antiglare |
| Pixel Pitch | 0.27 mm (2MP); 0.2115 mm (3MP); 0.165 mm (5MP) | 0.27 mm | 0.21075 mm | 0.165 mm |
| Native Resolutions | 1600x1200 (2MP); 2048x1536 (3MP); 2560x2048 (5MP) | 1600x1200 | 2048x1536 | 2560x2048 |
| Brightness | 1650 cd/m2 (2MP); 800 cd/m2 (3MP); 700 cd/m2 (5MP) | 1900 cd/m2 | 1700 cd/m2 | 1200 cd/m2 |
| Contrast Ratio | 850:1 (2MP); 1700:1 (3MP); 800:1 (5MP) | 1400:1 | 1400:1 | 1200:1 |
| Network Interface | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) |
| Active Display Size (HxV) | 432mm x 324mm (2MP); 433mm x 325mm (3MP); 422mm x 338mm (5MP) | 432.0mm x 324.0mm | 431.6mm x 323.7mm | 422.4mm x 337.9mm |
| Operating Temp. | 0°C ~ 35°C (2MP); 0°C ~ 40°C (3MP, 5MP) | 0°C ~ 40°C | 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temp. | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Humidity | 8% ~ 80% (non-condensing) | 20% ~ 80% | 20% ~ 80% | 20% ~ 80% |
| Transport/Storage Humidity | 5% ~ 85% (2MP); 5% ~ 95% (3MP, 5MP) | 10% ~ 90% | 10% ~ 90% | 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).