(76 days)
Not Found
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 any other section. The device is a display, not an image analysis or processing system that would typically incorporate AI/ML.
No
The device is described as a display for viewing medical images for diagnosis, and it explicitly states "The L218TL cannot be used for a life-support system." It is a diagnostic device, not a therapeutic one.
No
Explanation: The device is a display monitor used for viewing medical images, but it does not perform any diagnostic function itself. It supports the diagnostic process by presenting images for a physician to interpret.
No
The device description explicitly states it is a "21.3" Monochrome 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 is for displaying and viewing digital image diagnosis by trained physicians. This involves interpreting images generated from modalities like CT, MRI, HIS, and PACS, which are external to the patient's body.
- Device Description: The device is a medical display (monitor) that displays images. It does not perform any tests on biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Regulation Classification: The device is classified under "System, Image Processing, Radiological (CLASS II CFR 892.2050)". This classification is for devices used in radiology for processing and displaying medical images, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components and processes associated with IVDs.
In summary, the L218TL Monochrome display is a medical device used for displaying radiological images for diagnostic purposes, but it does not perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The L218TL Monochrome 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 L218TL 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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Medical Display, L218TL is a 21.3" Monochrome 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
System, Image Processing, Radiological (CLASS II CFR 892.2050)
Mentions AI, DNN, or ML
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Input Imaging Modality
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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).
0
i
KC90215
Page 1 of 2
510(K) Summary of Safety and Effectiveness
As required by 807.92
1. DEVICE ESTABLISHMENT AND CONTACT PERSON
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
APR 1 5 2009
2. COMPANY REISTRATION NUMBER 3003623028
3. DATE SUMMARY PREPARED
15 December 2008
4. DEVICE NAME
| Trade Name: | MD213 MG 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | L218TL |
| Common Name: | Monochrome LCD Monitor, Monochrome Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
4. PREDICATE DEVICE
MDM2130-3NC 21.3" 3MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063266).
DEVICE DESCRIPTION ર.
V
Medical Display, L218TL is a 21.3" Monochrome 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.
1
KC90215
Page 2 of 2
DEVICE OF INTENDRD USE 6.
The L218TL monochrome 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 L218TL 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.
7. CONCLUSION
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 MDM2130-3NC by Chi Lin Technology Co., Ltd. (K063266).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design that resembles an abstract human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEC Display Solutions, Ltd. c/o Mr. Morten Simon Christensen Asst. Manager, Program Reviewer UL Health Sciences Underwriters Laboratories, Inc. . 455 E. Trimble Road SAN JOSE CA 95131-1230
APR 1 5 2009
Re: K090215
Trade/Device Name: Medical Display, L218TL 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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Page 2
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.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.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 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
Indications for Use
510(k) Number (if known):
Device Name: Medical Display, L218TL
Indications For USe: The L218TL Monochrome 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 L218TL 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 V (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)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
98
510(k) Number
vi