(18 days)
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The document describes a medical display monitor and its technical specifications, with no mention of AI or ML capabilities for image analysis or processing beyond standard display functions.
No
The device is a medical display, identified as a monochrome LCD monitor, intended for displaying and viewing digital images for diagnosis by trained physicians. It does not directly provide therapy or treatment.
No
This device is a medical display, a monitor, which is used for viewing digital images for diagnosis. It does not perform the diagnosis itself.
No
The device description explicitly states it is a "21.3" Monochrome LCD monitor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for displaying and viewing digital images for diagnosis by trained physicians. This involves interpreting images generated from medical imaging modalities (CT, MRI, etc.), not analyzing samples taken from the human body (like blood, urine, tissue).
- Device Description: It's a medical display monitor. Its function is to present visual information, not to perform tests on biological samples.
- Mentions image processing: While it mentions "Image Processing, Radiological," this refers to the processing of medical images, not the processing of biological samples for diagnostic purposes.
- Input Imaging Modality: The inputs are imaging modalities like CT, MRI, HIS, and PACS, which produce images, not biological samples.
- No mention of analyzing biological samples: There is no indication that this device interacts with or analyzes any kind of biological material.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This display monitor does not fit that description.
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Intended Use / Indications for Use
The MD211G3 gray scale 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.
MD211G3 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, MD211G3 is a 21.3" Monochrome 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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test items according to "Assessment of Display Performance for Medical Imaging Systems" published by American Association of Physicists in Medicine (AAPM) Task Group 18 were performed to device MD211G3. The complete system configuration as well as the device verification and validation have also been assessed in-house. The results showed that all the testing items met the criteria. The predicate device - L218TL also has the above mentioned tests performed and has the same results and this demonstrates that MD211G3 and L218TL are equivalent in terms of performance.
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).
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§ 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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510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Saohiko Shimazu 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
21 June 2012
.
4. DEVICE NAME
| Trade Name: | MD211G3 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD211G3 |
| Common Name: | Monochrome LCD Monitor, Monochrome 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, MD211G3 is a 21.3" Monochrome 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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6. DEVICE OF INTENDED USE
The MD211G3 gray scale display is intended to be use 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.
MD211G3 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 | L218TL | MD211G3 | |
|---|---|---|---|
| 510(k) Number | K090215 | ||
| Panel Size and Type | 21.3" TFT Monochrome LCD Monitor | 21.3" TFT Monochrome LCD Monitor | |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.212 mm x 0.212mm | |
| Display Monochromes | 10-bit (1024 grey tones) with 3061 total colors | 10-bit (1024 grey tones) with 3061 total colors | |
| Viewing Angles (°) | H:176, V:176 | H:176, V:176 | |
| Scanning Frequency (H, V) | 31.5-95.4kHz, 30-85 Hz | 31.5-95.4kHz, 30-85 Hz | |
| Native Resolutions | 2048X1536 | 2048X1536 | |
| Brightness | 400 cd/m² calibrated, | ||
| 1450 cd/m² Max. | 400 cd/m² calibrated, | ||
| 1450 cd/m² Max. | |||
| Contrast Ratio | 900 : 1 (typical) | 900 : 1 (typical) | |
| DOT Clock | 162 MHz | 188 MHz | |
| Input Signals | Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital) | Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital) | |
| Input Terminals | DVI-D, D-sub | DVI-D, D-sub | |
| USB (option) / Standard | No | No | |
| Active Display Size (H x V) | Landscape: 433mmX325mm | ||
| Portrait: 325X433mm | 433 mm x 325 mm | ||
| 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 user | |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50-60Hz | |
| Power Consumption | 98W (Max) | 100W (Max) | |
| Power Save Mode |