(13 days)
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No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No.
The device is a medical display intended for viewing digital images for diagnosis by trained physicians, not for direct therapeutic intervention.
No
The device is a medical display used for viewing digital images for diagnosis but does not perform the diagnosis itself. Its function is to display images for a physician to interpret.
No
The device description explicitly states it is a "24.1" Color LCD monitor," which is a hardware component.
Based on the provided information, the MD242C2 color display is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "displaying and viewing of digital images for diagnosis by trained physicians." This describes a display device used for visualizing medical images, not a device that performs tests on biological samples or provides diagnostic information based on such tests.
- Device Description: The description confirms it's a "Color LCD monitor that displays image for medical use." This aligns with a display device, not an IVD.
- 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.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
The device is clearly intended for displaying medical images generated by other diagnostic modalities (like CT, MRI, etc.) for interpretation by a physician. This falls under the category of a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
The MD242C2 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. MD242C2 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, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) 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)
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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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K132587
Page 1 of 4
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON l.
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: | MD242C2 24.1" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD242C2 |
| 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, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
1
DEVICE OF INTENDED USE 6.
The MD242C2 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.
MD242C2 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 | MD242C2 |
|---|---|---|
| 510(k) Number | K083907 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 24.1" 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:178, V:178 |
| Scanning Frequency (H, V) | 31.5-91.1kHz, 50-85 Hz | 31.5-93.8, 118.4kHz, 50-85 Hz |
| Native Resolutions | 1600X1200 | 1920X1200 |
| Brightness | 400 cd/m² calibrated, | |
| 850 cd/m² Max. | 180 cd/m² calibrated, | |
| 350 cd/m² Max. | ||
| Contrast Ratio | 1050 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 162 MHz | 202.5 MHz (Max) (Analog) |
| 162 MHz (Max) (Digital) | ||
| Input Signals | Three connectors: one D-sub | |
| analog VGA: and two DVI-I | ||
| (VGA analog or digital) | Three connectors: one DVI port, | |
| one Display port, one HDMI | ||
| port | ||
| Input Terminals | DVI-D, D-sub | DVI-D, Display port, HDMI |
| port | ||
| USB (option) / Standard | No | No |
| Active Display Size (H x | Landscape: 432mmX324mm | Landscape: 518.4mmX324mm |
| V) | Portrait: 324X432mm | Portrait: 324X518.4mm |
| Viewable Image Size | 540 mm (diagonal) | 540 mm (diagonal) |
| Luminance Calibration | Software | Software |
| Default Gamma | DICOM part 14 + off, 1.8,2.0,2.2 | |
| 1.8.2.0,2.2 | DICOM part 14 | |
| user | ||
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 100W (Max) | 38.4W (Max) |
| Power Save Mode |