LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50

K052120 · Heeyoung Co., Ltd. · LLZ · Dec 16, 2005 · Radiology

Device Facts

• Record ID: K052120
• Device Name: LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50
• Applicant: Heeyoung Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

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.

Device Story

Lumimed Monochrome LCD Monitors (MM 20, MM 30, MM 50) are high-resolution displays for medical images, including X-ray and MRI. Monitors receive video input from a VREngine MD/SMD Series graphics card installed in a PC. Devices feature resolutions ranging from 1600x1200 to 2560x2048. Optional photo sensors (Gretagmacbeth GFU12-SEQ01) and software allow for luminance calibration. Monitors are used in clinical settings by healthcare professionals to view diagnostic images. Output facilitates clinical decision-making by providing high-fidelity visualization of radiological data. Benefits include accurate image representation for diagnostic review.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

TFT monochrome LCD panels; resolutions 1600x1200 to 2560x2048; universal switching power supply (AC100V-240V, 50/60Hz); USB functionality; optional external photo-sensor for calibration; EN 60601-1 safety certified; portrait or landscape orientation.

Indications for Use

Indicated for use in medical imaging applications, excluding digital mammography, where the monitor meets system-specific performance requirements.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• RadiForce G51, 5 Megapixel Monochrome LCD Monitor (K042755)

Submission Summary (Full Text)

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052120

## EXHIBIT 2

510(k) Summary Heeyoung Co., Ltd 1048-8, Shingil-dong, Danwon-gu, Ansan-city, Kyunggi-do, 425-839, Korea Tel: [phone] Fax: [phone] Contact: Youngho Ro, Vice-President Date: December 14, 2005

- 1. 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
- 2. Equivalent legally marketed devices: RadiForce G51, 5 Megapixel Monochrome LCD Monitor (K042755, EIZO NANAO Corp.)
- 3. 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.
- 4. 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.

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| Items | RadiForce G51 | Lumimed MM20 | Lumimed MM30 | Lumimed MM50 |
|------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------|
| 510(k) Number | K042755 | New | New | New |
| Manufacturer | Eizo Nano<br>Corporation | Heeyoung Co., Ltd | Heeyoung Co., Ltd | Heeyoung Co., Ltd |
| Panel Size and<br>Type | 21.3" TFT<br>monochrome LCD<br>display | 21.3" TFT<br>monochrome LCD<br>display | 21.3" TFT<br>monochrome LCD<br>display | 20.1" TFT<br>monochrome LCD<br>display |
| Pixel Pitch | 0.165mm x<br>0.165mm | 0.270mm x 0.270mm | 0.2115mm x 0.2115 | 0.156mm x 0.156mm |
| Available Cabinet<br>Colors | Black | Black | Black | Black |
| Native Resolutions | 2048x2560 (portrait)<br>2560x2048(landscap<br>e) | 1200x1600(portrait)<br>1600x1200(landscape) | 1536x2048(portrait)<br>2048x1536(landscape) | 2048x2560 (portrait)<br>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<br>4pin(Remote In)<br>Mini DIN 8pin<br>(Remote Out) | Mini DIN 4pin (Remote<br>In)<br>Mini DIN 8pin (Remote<br>Out) | Mini DIN 4pin(Remote<br>In)<br>Mini DIN 8pin (Remote<br>Out) | Mini DIN 4pin (Remote<br>In)<br>Mini DIN 8pin (Remote<br>Out) |
| Active Display<br>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<br>Calibration | Software (Optional)<br>Photo-sensor<br>(Optional) | Software (Optional)<br>Photo-sensor (Optional) | Software (Optional)<br>Photo-sensor (Optional) | Software(Optional)<br>Photo-sensor (Optional) |
| Power | AC 100V-120V /200V-<br>240V,<br>50/60Hz | AC100V-120V/200V-<br>240V,<br>50/60Hz | AC 100V-120V /200V-<br>240V,<br>50/60Hz | AC 100V-120V /200V-<br>240V,<br>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.

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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 [phone] or [phone] 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

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## 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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