(41 days)
Not Found
No
The 510(k) summary describes a medical monitor, which is a display device. There is no mention of any software, algorithms, or processing capabilities that would suggest the use of AI or ML. The description focuses solely on the monitor's physical characteristics and display capabilities.
No.
The device is a medical monitor used for displaying images for diagnosis, and it does not directly treat or alleviate a medical condition.
Yes
The device is a monitor used for displaying and viewing medical images "for diagnosis by trained medical practitioners," which explicitly states its role in the diagnostic process.
No
The device description clearly 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Monochrome LCD Monitor" used for "displaying and viewing medical images". It does not interact with or analyze biological specimens.
- Intended Use: The intended use is for displaying images for diagnosis, not for performing tests on samples.
Therefore, the MDL2121A (ME253i2) falls under the category of a medical image display device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) 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
MDL2121A (ME25312) is a 21.3-inch Monochrome LCD Monitor that supports DVI video signal and provides UXGA (1600 x 1200) 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MDL2109A (K050617)
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
TOTOKU
206810
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan | NOV 30 2006 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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 | |
| Device Name: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME25312) | |
| Common Name: | MDL2121A, ME25312, 2M Monitor/Display | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | MDL2109A (K050617) | |
| Device Description: | MDL2121A (ME25312) is a 21.3-inch Monochrome LCD Monitor
that supports DVI video signal and provides UXGA (1600 x 1200)
resolution for both landscape and portrait display. | |
| Intended Use: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME25312)
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: | MDL2121A (ME25312) shares the same characteristics with our
predicate device MDL2109A (K050617) except for the newly-
developed luminance equalizer. | |
Page
1
Image /page/1/Picture/1 description: The image shows a circular seal or logo. The seal features the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter of the circle. In the center of the seal, there is a stylized graphic consisting of three curved lines or shapes, possibly representing a symbol or emblem associated with the department.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
NOV 3 U 2006
Re: K063198
R003176
Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) 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 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 (Premarket Approval), 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.
Image /page/1/Picture/12 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. The word "Centennial" is written in a cursive font below the letters. There are three stars at the bottom of the logo.
Protecting and Promoting Public Health
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean FICAS oc advised that I DA 5 lissualise over device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any I coclar sunates and registerients, including, but not limited to: registration and listing (21 Comply with an the Not 31equirements) (1); good manufacturing practice requirements as set CIN I at 007), labeling (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (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) I mis letter will and w you'ls substantial equivalence of your device of your device to a legally prematication. The subts 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 If you desire specific acrise to you 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 (21 Of Icrom 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 MDL2121A (ME253i2) Indications for Use:
21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) 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)
Nancyc Brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
TOTOKU ELECTRIC CO., LTD.