(55 days)
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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 other sections. The device is a display, not an image analysis or processing system that would typically incorporate AI/ML.
No
The device is a medical display used for viewing digital image diagnoses, not for treating or preventing disease.
No
Explanation: The device is a display monitor used for viewing digital image diagnosis rather than performing the diagnosis itself. Its function is to present images, not to analyze them or make diagnostic determinations.
No
The device description explicitly states it is a "20.1" monochrome LCD monitor," which is a hardware component.
Based on the provided information, the MD205MG-1 grayscale display is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the MD205MG-1 is used for displaying and viewing digital image diagnosis (like CT, MRI, mammography) and is connected to equipment that generates these images. It does not interact with or analyze biological samples.
- The device is classified under "System, Image Processing, Radiological". This classification falls under the realm of medical imaging and radiology, not in vitro diagnostics.
- The intended use is for displaying images for diagnosis by trained physicians. This is a core function of medical imaging displays, not IVD devices.
Therefore, the MD205MG-1 is a medical display used in the field of medical imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography system by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
System, Image Processing, Radiological (CLASS II CFR 892.2050)
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, HIS, and PACS, digital mammography system
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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ਕਿ 2001 (Video
510(K) Summary of Safety and Effectiveness
As required by 807.92
| 1. | DEVICE ESTABLISHMENT AND CONTACT PERSON |
|---|---|
| Mr. Shuichi Kino | |
| General Manager | |
| NEC Display Solutions Ltd. | |
| 686-1 Nishioi, Oi-Machi | |
| Ashigarakami-Gun, Kanagawa | |
| Japan 258-8533 | |
| Ph: +81-465-85-2376 |
OCT 23 2008
| 2. | COMPANY REISTRATION NUMBER |
|---|---|
| ---- | ---------------------------- |
AUG 29 20083003623028
DATE SUMMARY PREPARED 3.
01 July 2008
DEVICE NAME 4.
| Trade Name: | Medical Display, MD205MG-1 |
|---|---|
| Common Name: | Monochrome LCD Monitor, Monochrome Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
PREDICATE DEVICE 4.
MDM2010-5NC 20.1" 5MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063269).
5. DEVICE DESCRIPTION
Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
K17
1
6. DEVICE OF INTEND USE
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography system by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
7. CONCLUSION
Medical Display, MD205MG-1 has the same intended use as the predicate device MDM2010-5NC. Though the brand name and model name are different, MD205MG-1 is a modified device from MDM2010-5NC. The only differences are panel, luminance and scanning frequency. The modified device is sent to test against standards: UL60601-1, EN60601-1-2, PAS-1054, DDN6868-57 and ISO13406-2 and based on the Risk Analysis we know that they do not effect the device efficiency nor raise any safety issue. The device does not contact with the patient nor does it control any life-sustaining device. Therefore we concluded that it is substantially equivalent to MDM2010-5NC by CHILIN Technology Co., Ltd. (K063269).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers. The symbol is black, and the text is also likely black or a dark color.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2008
NEC Display Solutions Ltd. % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Coordinator, Program Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
Re: K082493
Trade/Device Name: Medical Display, MD205MG-1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2008 Received: October 14, 2008
Dear Mr. Christensen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
hoque An Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number (if known): K082493
Device Name: Medical Display, MD205MG-1
Indications for use: The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Rumer
(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number