(15 days)
Not Found
No
The summary describes a medical display monitor and its technical specifications, focusing on image display quality and compliance with standards like DICOM. There is no mention of AI, ML, or any algorithms that process or interpret images beyond basic display functions. The "Image Processing" classification refers to the device's role in displaying radiological images, not necessarily advanced AI-driven processing.
No
The device is a medical display used for viewing digital images for diagnosis, not for treating conditions.
No
The device is a medical display, specifically an LCD monitor, designed for viewing digital images for diagnosis. It does not perform the diagnosis itself.
No
The device description explicitly states it is a "31.5" Color LCD monitor," which is a hardware component. The 510(k) summary focuses on the performance of this physical display.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MD322C8 is a medical display intended for displaying and viewing digital images for diagnosis. It receives images from modalities like CT, MRI, HIS, and PACS.
- Lack of Sample Analysis: The device itself does not perform any analysis on biological samples. Its function is solely to present visual information derived from imaging equipment.
- Intended Use: The intended use clearly states it's for "displaying and viewing of digital images for diagnosis." This aligns with the function of a medical image display, not an IVD.
- Device Description: The description confirms it's a "Color LCD monitor that displays image for medical use."
While the device is used in a medical context for diagnosis, its role is to present images, not to analyze biological samples in vitro.
N/A
Intended Use / Indications for Use
The MD322C8 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.
MD322C8 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
PGY
Device Description
Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
Not Found
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, hospital
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)
Display Testing:
- Display Reflection
- Luminance Response
- Luminance Uniformity
- Display Resolution
- Display Noise
- Veiling Glare
- Display Chromaticity
- Miscellaneous Tests
Summary: Test results showed minor differences between MD322C8 and MD210C3, however these differences are minor and were within the acceptable range of DICOM part 14.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
February 6, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NEC Display Solutions Ltd % Mr. Tony Hsu Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec 2, Wunhua 1st Road, Linkuo, New Taipei City, 24447 TAIWAN
Re: K150145
Trade/Device Name: 31.5 inch Color LCD Monitor MD322C8 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: January 15, 2015 Received: January 22, 2015
Dear Mr. Hsu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150145
Device Name Medical Display, MD322C8
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
The MD322C8 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.
MD322C8 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary of Safety and Effectiveness
As required by 807.92
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.
15th January 2015
4. DEVICE NAME
| Trade Name: | MD322C8 31.5" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD322C8 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR |
| 892.2050) | |
| Product Code: | PGY |
PREDICATE DEVICE 4.
MD210C3 3MP Color LCD Monitor by NEC Display Solutions Ltd. (K142951)
ട. DEVICE DESCRIPTION
Medical Display, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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DEVICE OF INTENDED USE 6.
The MD322C8 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.
MD322C8 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 | MD210C3 | MD322C8 |
|---|---|---|
| 510(k) Number | K142951 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 31.5" TFT Color LCD Monitor |
| Pixel Pitch | 0.212 mm x 0.212mm | 0.182 mm x 0.182mm |
| Display Color | 1,073,741,824 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:178, V:178 |
| Scanning Frequency (H, V) | 31.5-94.8, 126.3kHz, 30, 50-85 Hz | 31.5-133.2kHz, 24-87 Hz |
| Native Resolutions | 2048X1536 (Landscape) | |
| 1536X2048 (Portrait) | 3840X2160 (Landscape) | |
| 2160X3840 (Portrait) | ||
| Brightness | 400 cd/m2 calibrated, | |
| 800 cd/m² Max. | ||
| Contrast Ratio | 1400 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 214.3 MHz | 214.3 MHz |
| Input Signals | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP | Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP |
| Input Terminals | DVI-D, Display port | DVI-D, Display port |
| USB (option) / Standard | No | No |
| Active Display Size (H x | ||
| V) | Landscape: 433mmX325mm | |
| Portrait: 325X433mm | Landscape: 697.9mmX392.6mm | |
| Portrait: 392.6X697.9mm | ||
| Viewable Image Size | 540 mm (diagonal) | 801 mm (diagonal) |
| 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 |
| Input Rating | 1.1-0.44A | 1.51-0.6A |
| Power Save Mode |