(134 days)
Not Found
No
The description focuses on the hardware specifications of monochrome LCD monitors and their use in displaying medical images, with no mention of AI or ML capabilities for image analysis or processing.
No.
The device is a monitor for displaying medical images, not for providing therapy. It is used in diagnostic applications.
No
The device is a monochrome LCD monitor designed to display medical images. While it's used in medical image applications, its function is for display, not for interpreting or analyzing the images to diagnose a condition.
No
The device description explicitly states it is a "Monochrome LCD Monitor" and details hardware components like resolutions, USB functions, power supplies, and graphics cards. It also mentions safety certifications for hardware.
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 description clearly states that this device is a monochrome LCD monitor used to display medical images like X-ray and MRI. It is a display device, not a test that analyzes biological samples.
- Intended Use: The intended use is for displaying medical images in various applications, not for performing diagnostic tests on patient samples.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, this device falls under the category of medical imaging display devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specified by the manufacturer of the system.
Product codes
90 LLZ
Device Description
Monochrome LCD Monitors (MM 20, MM 30 and MM 50) are used to display images such as X-ray, or MRI images. These models have resolutions of: 2560 X 2048, 2048 X 1536 and 1600 X 1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by Gretagmacbeth. These models are certified to the EN 60601-1 medical safety standard. The monitors use universal switching power supplies compatible with AC100V-120V/200V-240V ,50/60Hz. The graphics card needed for the personal computer is the VREngine MD/SMD Series. The monitors may be deployed in the portrait or the landscape position.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing was performed according to internal company procedures and the monitors were safety certified.
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).
0
052120
EXHIBIT 2
510(k) Summary Heeyoung Co., Ltd 1048-8, Shingil-dong, Danwon-gu, Ansan-city, Kyunggi-do, 425-839, Korea Tel: 82-31-491-5585 Fax: 82-31-491-5510 Contact: Youngho Ro, Vice-President Date: December 14, 2005
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- Identification of the Device: feshantones - Trade Name: "Lumimed Monochrome LCD Monitor" (Models: MM 20, MM 30, MM50) Classification Name: System, Image Processing, Radiological, Product Code 90 LLZ Common/Usual Name: Radiological Image Processing System, LCD Monitor
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- Equivalent legally marketed devices: RadiForce G51, 5 Megapixel Monochrome LCD Monitor (K042755, EIZO NANAO Corp.)
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- Indications for Use (intended use): Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specified by the manufacturer of the system.
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- Description of the device: Monochrome LCD Monitors (MM 20, MM 30 and MM 50) are used to display images such as X-ray, or MRI images. These models have resolutions of: 2560 X 2048, 2048 X 1536 and 1600 X 1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by Gretagmacbeth. These models are certified to the EN 60601-1 medical safety standard. The monitors use universal switching power supplies compatible with AC100V-120V/200V-240V ,50/60Hz. The graphics card needed for the personal computer is the VREngine MD/SMD Series. The monitors may be deployed in the portrait or the landscape position.
Image /page/0/Picture/8 description: The image shows two x-ray images of a foot. The x-rays are displayed on what appears to be a computer monitor. The foot is shown in profile, with the toes pointing to the left. The bones of the foot are clearly visible in the x-ray.
1
| Items | RadiForce G51 | Lumimed MM20 | Lumimed MM30 | Lumimed MM50 |
|---|---|---|---|---|
| 510(k) Number | K042755 | New | New | New |
| Manufacturer | Eizo Nano | |||
| Corporation | Heeyoung Co., Ltd | Heeyoung Co., Ltd | Heeyoung Co., Ltd | |
| Panel Size and | ||||
| Type | 21.3" TFT | |||
| monochrome LCD | ||||
| display | 21.3" TFT | |||
| monochrome LCD | ||||
| display | 21.3" TFT | |||
| monochrome LCD | ||||
| display | 20.1" TFT | |||
| monochrome LCD | ||||
| display | ||||
| Pixel Pitch | 0.165mm x | |||
| 0.165mm | 0.270mm x 0.270mm | 0.2115mm x 0.2115 | 0.156mm x 0.156mm | |
| Available Cabinet | ||||
| Colors | Black | Black | Black | Black |
| Native Resolutions | 2048x2560 (portrait) | |||
| 2560x2048(landscap | ||||
| e) | 1200x1600(portrait) | |||
| 1600x1200(landscape) | 1536x2048(portrait) | |||
| 2048x1536(landscape) | 2048x2560 (portrait) | |||
| 2560x2048(landscape) | ||||
| Brightness | 700cd/m2 | 1000cd/m2 | 900cd/m2 | 850cd/m2 |
| Contrast Ratio | 600:1 | 700:1 | 700:1 | 600:1 |
| Dot Clock | 152MHz | 125MHz | 130MHz | 162MHz |
| Serial Ports | Mini DIN | |||
| 4pin(Remote In) | ||||
| Mini DIN 8pin | ||||
| (Remote Out) | Mini DIN 4pin (Remote | |||
| In) | ||||
| Mini DIN 8pin (Remote | ||||
| Out) | Mini DIN 4pin(Remote | |||
| In) | ||||
| Mini DIN 8pin (Remote | ||||
| Out) | Mini DIN 4pin (Remote | |||
| In) | ||||
| Mini DIN 8pin (Remote | ||||
| Out) | ||||
| Active Display | ||||
| Size (HxV) | 337.9 x 422.4mm | 432(H) x 324(V) | 432(H) x 324(V) | 399(H) x 319(V) |
| Dimensions(WxHxD | 388 x 572 x 83.5mm | 472 x 495 x92 | 472 x 495 x92 | 438 x 458 x 98 |
| Luminance | ||||
| Calibration | Software (Optional) | |||
| Photo-sensor | ||||
| (Optional) | Software (Optional) | |||
| Photo-sensor (Optional) | Software (Optional) | |||
| Photo-sensor (Optional) | Software(Optional) | |||
| Photo-sensor (Optional) | ||||
| Power | AC 100V-120V /200V- | |||
| 240V, | ||||
| 50/60Hz | AC100V-120V/200V- | |||
| 240V, | ||||
| 50/60Hz | AC 100V-120V /200V- | |||
| 240V, | ||||
| 50/60Hz | AC 100V-120V /200V- | |||
| 240V, | ||||
| 50/60Hz |
| Safety and Effectiveness. comparison to predicate device. | |
|---|---|
Testing information and Conclusion
I comig information and over and over in are substantially equivalent to the predicate device.
Testing was performed according to internal company procedures and the monitors were safety certified.
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 2005
Heevoung Co., Ltd. % Mr. Daniel Kamm Regulatory Engineer P.O. Box 7007 DEERFIELD IL 60015 Re: K052120
Trade/Device Name: Lumimed Monochrome LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 9, 2005 Received: November 29, 2005
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becalled by equivalent (for the indications for use stated in above and nave determine a keed predicate devices marketed in interstate commerce prior to the enclosure) to regally mankelou production Device Amendments, or to devices that have been May 20, 1770, the enabilities 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 do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the generaliation, 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 (Premarket If your device is onastilita (000 as the Aditional controls. Existing major regulations affecting your Apploval), it thay of subject to back aderal 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 docs not mean that I Rast be advised marr 2211 in that your device complies with other requirements of the Act or any I DA has made a accerminations administered by other Federal agencies. You must comply with all the r cacrar statues and regulating, but not limited to registration and listing (21 CFR Part 807); labeling (2) CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS). (2) CTT Fart 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The FDA miding of sacomment of your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spectic advice for your device on our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation enation on your responsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon 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): K052120
"Lumimed Monochrome LCD Monitor" Device Name: (Models: MM 20, MM 30, MM50).
Monochrome LCD Monitors intended to be used in various kinds of medical image applications Monocinome LCD Momoro "mentors" the device complies with the performance requirements specified by the manufacturer of the system.
Prescription Use X__ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Rogdon
Division S Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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