(15 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 classified as a "Medical Display" and "System, Image Processing, Radiological," which are standard classifications for display hardware and basic image processing, not necessarily indicative of AI/ML.
No
The device is a medical display intended for viewing digital image diagnosis; it does not directly treat or diagnose conditions.
No
This device is a medical display used for viewing digital image diagnoses. It does not perform the diagnosis itself. Its purpose is to present images to trained physicians for their diagnostic interpretation.
No
The device description explicitly states it is a "29.8" 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 (in vitro).
- 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.
- CFR Classification Name: The classification "System, Image Processing, Radiological" (892.2050) is for devices that process and display radiological images, not for in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In summary, the L307TD Color display is a medical device used for displaying medical images, which falls under the category of radiological image processing systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The L307TD 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 L307TD 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, L307TD is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) 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
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)
MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579)
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).
0
JAN 14 2009
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON 1.
Mr. Osamu Lseki
General Manager
NEC Display Solutions Ltd.
4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan
Ph: +81-465-85-2376
COMPANY REISTRATION NUMBER 2. 3003623028
DATE SUMMARY PREPARED 3.
01 October 2008
4. DEVICE NAME
Trade Name:
LCD3090WQXi or MD304MC 29.8" Diagnostic Imaging LCD monitor L307TD Model Number: Color LCD Monitor, Color Diagnostic Display, etc. Common Name: System, Image Processing, Radiological (CLASS II CFR Classification Name: 892.2050)
4. PREDICATE DEVICE
MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579).
DEVICE DESCRIPTION 5.
Medical Display, L307TD is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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6. INTENDRD USE OF DEVICE
The L307TD 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 L307TD 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
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/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three bars representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NEC Display Solutions Ltd. % Mr. Marc M. Mouser Manager/FDA Office Coordinator Underwriters Laboratories 2600 N.W. Lake Road CAMAS WA 98607-8542
JAN 1 4 2009
Re: K083916
Trade/Device Name: Medical Display, L307TD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2008
Received: December 30, 2008
Dear Mr. Mouser:
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.
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.
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Page 2
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 (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.
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,
Janine M. Morris
anine 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): K O83916
Device Name: Medical Display, L307TD
Indications For USe. The L307TD 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.
TheL307TD 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 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 Device Evaluation (ODE)
n/M (Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number