(29 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a display monitor used for viewing medical images for diagnosis, not for providing medical therapy.
No
Explanation: The device is a display used for viewing digital images for diagnosis but does not perform the diagnosis itself. It is a tool used by trained physicians for diagnostic purposes, rather than being a diagnostic device.
No
The device description explicitly states it is a "21.3" Color LCD monitor," which is a hardware component.
Based on the provided information, the MD211C2 color display is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for displaying and viewing digital images for diagnosis by trained physicians. This is related to medical imaging, not the analysis of biological samples outside the body, which is the core function of IVD devices.
- Device Description: The device is a medical display monitor. Its function is to present images, not to perform tests on biological specimens.
- Regulation Classification: The device is classified under "System, Image Processing, Radiological (CLASS II CF 892.2050)". This classification is for devices used in medical imaging systems, not for IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components and functions of IVD devices.
In summary, the MD211C2 is a medical imaging display device used for viewing radiological images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MD211C2 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.
MD211C2 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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K130772
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510(K) Summary of Safety and Effectiveness
As required by 807.92
APR 1 8 2013
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Satoru Kotani Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393
2. COMPANY REISTRATION NUMBER 3003623028
DATE SUMMARY PREPARED 3.
12 October 2012
4, DEVICE NAME
| Trade Name: | MD211C2 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD211C2 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CF 892.2050) |
4. PREDICATE DEVICE
L217TG TFT Color LCD Monitor by NEC Display Solutions Ltd. (K083907)
DEVICE DESCRIPTION 5.
Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
v - l
1
DEVICE OF INTENDED USE 6.
The MD211C2 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.
MD211C2 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.
7. SE Comparison Table:
| Items | L217TG | MD211C2 |
|---|---|---|
| 510(k) Number | K083907 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 21.3" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm |
| Display Color | 16.777,216 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:176, V:176 |
| Scanning Frequency | ||
| (H, V) | 31.5-91.1kHz , 50-85 Hz | 31.5-74.5, 99.4kHz, 50-85 Hz |
| Native Resolutions | 1600X1200 | 1600X1200 |
| Brightness | 400 cd/m2 calibrated, | |
| 850 cd/m2 Max. | 400 cd/m2 calibrated, | |
| 900 cd/m2 Max. | ||
| Contrast Ratio | 1050 : 1 (typical) | 1400 : 1 (typical) |
| DOT Clock | 162 MHz | 165 MHz |
| Input Signals | Three connectors: one D-sub | |
| analog VGA; and two DVI-I | ||
| (VGA analog or digital) | Two connectors: one DVI-D, | |
| one display port (Display port | ||
| comply with standard V1.1a, | ||
| applicable to HDCP | ||
| Input Terminals | DVI-D, D-sub | DVI-D, Display port |
| USB (option) / Standard | No | No |
| Active Display Size (H x V) | Landscape: 432mmX324mm | |
| Portrait: 324X432mm | Landscape: 432mmX324mm | |
| Portrait: 324X432mm | ||
| 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 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 100W (Max) | 88W (Max) |
| Power Save Mode | K130772 510(k) |
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