(29 days)
Not Found
No
The document describes a medical display monitor and its intended use for viewing medical images. There is no mention of AI, ML, or any related technologies in the device description, intended use, or any other section. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a display monitor for medical images for diagnostic purposes, not for treatment or therapy.
No.
Explanation: This device is a medical display, which is specifically stated to be used for "displaying and viewing of digital images for diagnosis." While it aids in diagnosis by providing high-quality images, it does not perform the diagnostic function itself. The diagnostic function is performed by trained physicians who interpret the images displayed on this monitor.
No
The device description explicitly states it is a "21.3" Color LCD monitor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The MD211C3 is a display monitor. Its function is to display digital images for diagnosis. It does not interact with or analyze biological specimens.
- Intended Use: The intended use clearly states it's for "displaying and viewing of digital images for diagnosis." This is a display function, not an in vitro diagnostic function.
- Input Modalities: The input modalities (CT, MRI, HIS, PACS) are imaging systems, not systems that analyze biological specimens.
- Device Description: The description confirms it's a "Color LCD monitor that displays image for medical use."
Therefore, the MD211C3 falls under the category of a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MD211C3 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.
MD211C3 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, MD211C3 is a 21.3" Color LCD monitor that displays image for medical use, It provides 3 mega pixel (2048*1536) 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
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.)
Not Found
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.
L218TL 3MP Monochrome LCD Monitor by NEC Display Solutions Ltd. (K090215)
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.
Not Found
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).
0
K130770
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510(K) Summary of Safety and Effectiveness
APR 1 8 2013
As required by 807.92
1. DEVICE ESTABLISHMENT AND CONTACT PERSON
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
3. DATE SUMMARY PREPARED
12 October 2012
4. DEVICE NAME
| Trade Name: | MD211C3 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD211C3 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
4. PREDICATE DEVICE
L218TL 3MP Monochrome LCD Monitor by NEC Display Solutions Ltd. (K090215)
5. DEVICE DESCRIPTION
Medical Display, MD211C3 is a 21.3" Color LCD monitor that displays image for medical use, It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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K130770
Page 2 of 4
6. DEVICE OF INTENDED USE
The MD211C3 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 in conjunction with NEC approved display controllers.
MD211C3 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:
Comparison tables between MD211C3 & L218TL
| Items | L218TL | MD211C3 |
|---|---|---|
| 510(k) Number | K090215 | |
| Panel Size and Type | 21.3" TFT Monochrome LCD | |
| Monitor | 21.3" TFT Color LCD Monitor | |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.212 mm x 0.212mm |
| Display Color | 10-bit (1024 grey tones) with 3061 | |
| total colors | 1,073,741,824 | |
| Viewing Angles (") | H:176, V:176 | H:176, V:176 |
| Scanning Frequency | ||
| (H, V) | 31.5-95.4kHz , 30, 50-85 Hz | 31.5-94.8, 126.3kHz , 30, 50-85 Hz |
| Native Resolutions | 2048X1536 (Landscape) | |
| 1536X2048 (Portrait) | 2048X1536 (Landscape) | |
| 1536X2048 (Portrait) | ||
| Brightness | 400 cd/m² calibrated, | |
| 1450 cd/m² Max. | 400 cd/m² calibrated, | |
| 800 cd/m² Max. | ||
| Contrast Ratio | 900 : 1 (typical) | 1400 : 1 (typical) |
| DOT Clock | 162 MHz | 188 MHz |
| Input Signals | Two connectors: one D-sub analog | |
| VGA; and one DVI-I (VGA | ||
| analog or digital) | Two connectors: one DVI-D, | |
| one display port (Display port | ||
| comply with standard VI.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: 433mmX325mm | |
| Portrait: 325X433mm | Landscape: 433mmX325mm | |
| Portrait: 325X433mm | ||
| 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 | 98W (Max) | 88W (Max) |
| Power Save Mode | K130770 510(k) |
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