KOSTEC MEDICAL GRADE LDC MONITORS

K123944 · Kostec Co., Ltd. · LLZ · Sep 5, 2013 · Radiology

Device Facts

• Record ID: K123944
• Device Name: KOSTEC MEDICAL GRADE LDC MONITORS
• Applicant: Kostec Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.

Device Story

Medical LCD monitors (models KT-D213U5E, KT-D213Q5E, KT-D213V5E) display high-resolution medical images (X-ray, radiology, MRI, endoscopy). Device receives video input signals; high-performance image processing controller transforms signals for display on high-resolution LCD panels (resolutions up to 2560x2048). Used in clinical settings by healthcare professionals to view diagnostic images; output facilitates clinical decision-making by providing high-definition visualization of patient anatomy. Benefits include accurate, high-quality image representation for diagnostic review.

Clinical Evidence

Bench testing only. Device tested against international standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2, BS/EN 61000-3-2, BS/EN 61000-3-3), and DICOM (NEMA PS 3.1-3.18) compliance.

Technological Characteristics

High-resolution LCD panels; resolutions 1280x1024 to 2560x2048. Includes high-performance image processing controller. Connectivity supports DICOM standards. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for use in medical image applications, including X-ray, radiology, MRI, and endoscopy imaging. Excludes digital mammography. Intended for prescription use.

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

• LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 (K052120)

Submission Summary (Full Text)

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K123944
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# 510(K) Summary

| Submitter: | Kostec Co., Ltd. |
|------------------------|--------------------------------------------------------------------------------------------------------------|
| Address: | 2-108, Medical Industry Technocenter<br>1720-26, Taejang-dong<br>Wonju-si, Gangwon-do 220-962<br>South Korea |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Jae Kyeong, Sim |
| Date Summary Prepared: | 20 September 2012 |

SEP 0 5 2013

| Trade Name/Proprietary Name: | Medical LCD Monitor |
|------------------------------|------------------------------------------------------------------------------------------------------|
| Models: | KT-D213U5E<br>KT-D213Q5E<br>KT-D213V5E |
| Common Name/Usual Name: | System, Image Processing, Radiological (video monitor) |
| Classification Name: | System, Image Processing, Radiological |
| Product code: | LLZ |
| Device Class: | Class II |
| Regulation: | 21 CFR 892.2050 |
| Legally Marketed Device: | LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20,<br>MM 30 AND MM50<br>Heeyoung Company, Ltd.<br>K052120 |

## Description of Device:

The Medical LCD Monitors are designed for the purpose of medical applications such as X-ray, radiology, MRI or endoscopy imaging display. The high-resolution LCD panels with a resolution of 1280x1024,

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K123944
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1600x1200, 2048x1536 or 2560x2048, combined with a high-performance image processing controller, provides the users extremely high-definition and high-quality medical image displays. These medical monitors comply with international EMC/ safety standards.

#### Indications for Use:

The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.

### Comparison of Technical Characteristics:

In all material respects, the KOSTEC monitors are similar to the predicate device. Testing was performed according to internal company procedures and the monitors were safety certified to International Standards.

Though some differences between the new device and the predicate device exist, these differences do not raise new questions of safety and effectiveness.

## Compliance & Voluntary Standard Compliance

The subject device has been tested against and has passed the following standards:

- IEC 60601-1:2006, General Requirements for Electrical Safety
- . IEC 60601-1-2:2007, Electromagnetic Compatibility
- . NEMA PS 3.1-3.18:2009 Digital Imaging and Communication (DICOM) in Medicine
- . BS/EN 61000-3-2:2006+a2:2009, Electromagnetic compatibility (EMC). Liimits for harmonic current emissions
- . BS/EN61000-3-3:2008, Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection

### Conclusion

We have concluded that our devices are substantially equivalent to the predicate device. No new questions of safety and effectiveness have been raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, with three wavy lines below it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2013

Kostec Co., Ltd. % Rhonda Alexander, MS, MPA Senior Regulatory Specialist Registrar Corp 144 Research Drive HAMPTON VA 23666

Re: K123944

Trade/Device Name: Medical LCD Monitor (Models: KT-D213U5E, KT-D213Q5E and KT-D213V5E) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 26, 2013 Received: July 29, 2013

Dear Ms. Alexander:

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 than be Federal statutes and regulations administered by other Federal agencies. You must or any read 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 device-related duverse of only (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Alexander

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Smh.7)

for

Janine M. Morris 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): K123944

Device Name: Medical LCD Monitor

Models: KT.D213U5E, KT.D213Q5E, KT.D213V5E

Indications for Use:

The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)

sin.7)

(Division Sign-Off) Division of Radiological Health Office of In I'iro Diagnostics and Radiological Health

510(k) | K123944 ===

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