(41 days)
Not Found
No
The summary describes a medical monitor, which is a display device. There is no mention of AI/ML capabilities, image processing, or performance studies related to algorithmic analysis.
No.
This device is a medical monitor used for displaying medical images for diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the device is "to be used in displaying and viewing medical images for diagnosis by trained medical practitioners." This explicitly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "21.3-inch 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 "displaying and viewing medical images for diagnosis by trained medical practitioners." This describes a device used to visualize images generated by other medical equipment, not a device that performs tests on biological samples to provide diagnostic information.
- Device Description: The description is of a monitor, a display device. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measuring analytes or biomarkers
- Providing quantitative or qualitative results from a test
Therefore, the MDL2118A (ME355i2) is a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Product codes
LLZ
Device Description
MDL2118A (ME355i2) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (2048 x 1536) resolution for both landscape and portrait display.
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 medical practitioners
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
MDL2110A (K050485)
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
Image /page/0/Picture/0 description: The image shows the word "TOTOKU" in bold, sans-serif font. The letters are black and the background is white. There is a horizontal line underneath the word.
510(k) SUMMARY
- Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
- Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax:+81.268.34.5548
Date Prepared: October 17, 2006
- 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Device Name:
- Common Name: MDL2118A, ME355i2, 3M Monitor/Display
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: MDL2110A (K050485)
- Device Description: MDL2118A (ME355i2) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (2048 x 1536) resolution for both landscape and portrait display.
- Indended Use: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
- Substantial Equivalence: MDL2118A (ME355i2) shares the same characteristics with our predicate device MDL2110A (K050485) except for the newlydeveloped luminance equalizer.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle's perimeter.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 3 0 2006
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K063197
K063197
Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2006 Received: October 20, 2006
Dear Mr. Hasegawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device n & no reviewed your over of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass baced in also environd date of the Medical Device Amendments, or to devices that provision in the provision 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I spice 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.
Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the acronym "FDA" in large, bold letters. Underneath the acronym is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
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 of 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 894.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). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) Indications for Use:
21.3-inch (54cm) Monochrome LCD Monitor MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063192
TOTOKU ELECTRIC CO., LTD.