(58 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 "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a medical display for viewing digital image diagnoses, not directly involved in treating or mitigating a disease or condition. Its intended use is diagnostic, providing images for physicians.
No
Explanation: The device is a medical display, specifically a color LCD monitor, used for viewing and displaying digital image diagnoses, not performing the diagnosis itself. Its function is to present images for "more precise diagnose use" by physicians, positioning it as an output device rather than a diagnostic tool.
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 is for "displaying and viewing of digital image diagnosis by trained physicians." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description clearly states it's a "Medical Display" that "displays image for medical use." It focuses on image resolution and grayscale for diagnostic viewing.
- Mentions image processing: While it mentions "Image Processing," this is in the context of a "Radiological System," which aligns with image display and manipulation for diagnostic viewing, not in vitro testing.
- Input Imaging Modality: The input modalities (CT, MRI, HIS, and PACS) are all sources of medical images, not biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to display images generated by other diagnostic equipment.
N/A
Intended Use / Indications for Use
The L218TK 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 L218TK cannot be used for a life-support system.
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, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
Mentions image processing
Not Found
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
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): 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.
Not Found
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).
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
1083332
JAN - 9 2009
510(K) Summary of Safety and Effectiveness
As required by 807.92
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
2. COMPANY REISTRATION NUMBER
3003623028
DATE SUMMARY PREPARED 3.
24 October 2008
DEVICE NAME 4.
| Trade Name: | MD21M 21.3" Diagnostic Imaging LCD monitor |
|---|---|
| Model Number: | L218TK |
| 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 5.
Vİ
Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
1
DEVICE OF INTENDRD USE 6.
The L218TK 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 L218TK cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
7. CONCLUSION
vi
2MP Medical Color Display, L218TK has the same intended use as the predicate device MDC2130-2HC, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JAN - 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEC Display Solution Ltd. % Mr. Angus Hsu Prodigy Technology Consultant Co., Ltd. Safety Certification Service 1F, No. 181, Sec.2, Wunhua 1st Rd., Linkou Township Taipei 244 TAIWAN CHINA
Re: K083332
Trade/Device Name: Medical Display, L218TK Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 12, 2008 Received: November 12, 2008
Dear Mr. Hsu:
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 ffor 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.
Sincerely yours,
Laura B. Morris
anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Device Niame: Medical Display, L218TK
Indications For USe: The L218TK 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.
TheL218TK cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601 -1 certified equipment.
Prescription Use V (Part 21 CFR 801 Subpart D)
vii
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)
Stephan Remmler
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number