(72 days)
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No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
This device is a display monitor used to view digital images for diagnosis by physicians, it does not directly treat or alleviate a medical condition.
No
The device is a display monitor used to view digital images for diagnosis, but it does not perform the diagnosis itself.
No
The device description explicitly states it is a "29.8" 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:
- Intended Use: The intended use clearly states that the device is for "displaying and viewing of digital images for diagnosis by trained physicians." This describes a device used to present medical images, not a device that performs tests on biological samples to diagnose a condition.
- Device Description: The description confirms it's a "Color LCD monitor that displays image for medical use." It focuses on display characteristics like resolution and gamma, which are relevant to image viewing, not in vitro testing.
- Mentions image processing: While it mentions "Image Processing, Radiological," this refers to the system the display is part of, not the display itself performing image processing for diagnostic purposes on biological samples.
- Input Imaging Modality: The input modalities (CT, MRI, HIS, PACS) are all sources of medical images, not biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the MD302C4 is a medical display used to visualize images generated by other diagnostic modalities (like CT and MRI). It does not perform any diagnostic tests on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The MD302C4 color display is intended to be used for displaying 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.
MD302C4 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
LLZ
Device Description
Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
System, Image Processing, Radiological
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, hospital
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K 132587
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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KB33708
Page 1 of 4
510(K) Summary of Safety and Effectiveness
As required by 807.92
FEB 1 4 2014
DEVICE ESTABLISHMENT AND CONTACT PERSON l.
Mr. Naohiko Shimazu Senior Manager NEC Display Solutions Ltd. 686-1 NISHIOI, OI-MACHI, ASHIGARAKAMI-GUN, KANAGAWA, 258-8533, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393
2. COMPANY REISTRATION NUMBER
3003623028
3. DATE SUMMARY PREPARED
09 October 2013
4, DEVICE NAME
| Trade Name: | MD302C4 29.8" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD302C4 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR |
| 892.2050) |
PREDICATE DEVICE 4.
MD242C2 Color LCD Monitor by NEC Display Solutions Ltd. (K 132587)
DEVICE DESCRIPTION 5.
Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
1
6. DEVICE OF INTENDED USE
The MD302C4 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.
MD302C4 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 | MD242C2 | MD302C4 |
|---|---|---|
| 510(k) Number | ||
| Panel Size and Type | 24.1" TFT Color LCD Monitor | 29.8" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270mm | 0.251mm x 0.251mm |
| Display Color | 1,073,741,824 | 16,777,216 |
| Viewing Angles (°) | H:178, V:178 | H:178, V:178 |
| Scanning Frequency | ||
| (H, V) | 31.5-93.8, 118.4kHz, 50-85 Hz | 31.5-98.7 kHz, 50-85 Hz |
| Native Resolutions | 1920X1200 | 2560X1600 |
| Brightness | 180 cd/m² calibrated, | |
| 350 cd/m² Max. | 180 cd/m² calibrated, | |
| 340 cd/m² Max. | ||
| Contrast Ratio | 1000 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 202.5 MHz (Max) (Analog) | |
| 162 MHz (Max) (Digital) | 269 MHz (Max) | |
| Input Signals | Three connectors: one DVI port, | |
| one Display port, one HDMI port. | Three connectors: one DVI port, | |
| one Display port, one HDMI | ||
| port. | ||
| Input Terminals | DVI-D, Display port, HDMI port | DVI-D, Display port, HDMI port |
| USB (option) / Standard | No | No |
| Active Display Size (H x V) | Landscape: 518.4mmX324mm | |
| Portrait: 324X518.4mm | Landscape: 641mmX401mm | |
| Portrait: 401X641mm | ||
| Viewable Image Size | 540 mm (diagonal) | 756 mm |
| Luminance Calibration | Software | Software |
| Default Gamma | 1.8,2.0,2.2 DICOM part 14 | 1.8,2.0,2.2 DICOM part 14 |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 38.4W (Max) | 87W (Max) |
| Power Save Mode | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
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