(76 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is a medical display used for viewing digital image diagnoses. It does not provide any therapy or treatment.
No
The device is a medical display, which is a display and viewing device, not a diagnostic device itself. It is used in conjunction with other diagnostic equipment (like CT, MRI) for physicians to view images for diagnosis, but it does not perform the diagnosis.
No
The device description explicitly states it is a "21.3" Color LCD monitor," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "displaying and viewing of digital image diagnosis." This is about presenting images generated by other medical devices (like CT, MRI, etc.) for interpretation by a physician. It does not involve testing samples from the human body (like blood, urine, tissue) to provide diagnostic information.
- Device Description: The description confirms it's a "Medical Display" that "displays image for medical use." It focuses on image resolution and grayscale for viewing, not on analyzing biological samples.
- Lack of IVD Characteristics: The description and intended use do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information about a patient's health status based on sample analysis.
The device is a medical display intended for viewing diagnostic images, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The L218TJ color display is intended to be used for displaying of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards. The L218TJ cannot be used for a life-support system. This device must not be used in digital mammography. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Product codes
LLZ
Device Description
Medical Display, L218TJ is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
Yes
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)
Not Found
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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K090218
Page 1 of 2
510(K) Summary of Safety and Effectiveness
As required by 807.92
APR ] 5 2009
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Shuichi Kino Manager NEC Display Solutions Ltd. 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan Ph: +81-465-85-2376 Fax: +81-465-85-2378
COMPANY REISTRATION NUMBER 2. 3003623028
DATE SUMMARY PREPARED 3.
15 December 2008
4. DEVICE NAME
| Trade Name: | MD213 MC 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | L218TJ |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
4. PREDICATE DEVICE
MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579).
DEVICE DESCRIPTION ડ.
V
Medical Display, L218TJ is a 21.3" Color LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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DEVICE OF INTENDRD USE 6.
The L218TJ color display is intended to be used for displaying of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The L218TJ cannot be used for a life-support system.
This device must not be used in digital mammography.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
CONCLUSION 7.
V
These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).
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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEC Display Solutions, Ltd. c/o Mr. Morten Simon Christensen Assistant Manager, Program Reviewer UL Health Sciences Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
APR 1 5 2009
Re: K090218
Trade/Device Name: Medical Display, L218TJ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2009 Received: April 1, 2009
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.
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
(Gastroenterology/Renal/Urology) 21 CFR 876.xxx (240) 276-0115 21 CFR 884.xxx (Obstetrics/Gynecology) (240) 276-0115 (Radiology) (240) 276-0120 21 CFR 892.xxx (240) 276-0100 Other
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kogo218
Indications for Use
510(k) Number (if known):
Device Name: Medical Display, L218TJ
Indications For Use. The L218TJ Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The L218TJ cannot be used for a life-support system.
This device must not be used in digital mammography.
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)
Huler Lemen
Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
1630
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