(45 days)
Not Found
No
The summary describes a medical monitor for displaying images and does not mention any AI/ML capabilities or image processing features that would typically involve such technology.
No.
The device is a monitor used for displaying medical images for diagnosis, not for providing therapy or treatment.
Yes
The device is used for "displaying and viewing medical images for diagnosis," indicating its role in the diagnostic process.
No
The device description clearly states it is a "21.3-inch 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 "displaying and viewing medical images for diagnosis by trained medical practitioners." This describes a device used to visualize images generated from other medical procedures, not a device that performs tests on biological samples to diagnose conditions.
- Device Description: The description is for a "Color LCD Monitor," which is a display device.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information about a patient's health status based on laboratory tests
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This monitor's function is to display images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) 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
CDL2120A (CCL252i2) is a 21.3-inch Color 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CDL2113A (K050616)
Reference Device(s)
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
DEC - 4 2006_
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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 |
| Device Name: | 21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) |
| Common Name: | CDL2120A, CCL252i2, 2M Monitor/Display |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | CDL2113A (K050616) |
| Device Description: | CDL2120A (CCL252i2) is a 21.3-inch Color 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) Color LCD Monitor CDL2120A (CCL252i2) 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: | CDL2120A (CCL252i2) shares the same characteristics with our
predicate device CDL2113A (K050616) except for the newly-
developed luminance equalizer. |
300 Oya, Ueda, Nagano 386-0192 Japan
1
Image /page/1/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines representing its wings and two wavy lines representing its legs.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
2006 DEC 4
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K063199
Trade/Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) 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/10 description: The image is a circular logo with the text "1926-2026" at the top. Below the text is a large "PA" in bold letters. Underneath "PA" is the word "Centennial" in a cursive font. 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 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
Page 2 -
3
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) Indications for Use:
21.3-inch (54cm) Color LCD Monitor CDL2120A (CCL252i2) 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 Brogdon
and Radiological Devices 510(k) Numl