(18 days)
No
The summary describes a medical monitor for displaying images and does not mention any AI/ML capabilities or image processing features typically associated with AI/ML.
No
The device is a monitor used for displaying medical images for diagnosis, not for providing therapy.
No
The document states that the device is a monitor used for displaying and viewing medical images for diagnosis, not for performing the diagnosis itself.
No
The device description explicitly states it is a 20.8-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". This describes a device used to visualize data generated by other medical devices (like imaging equipment), not a device that performs tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Device Description: The description is of a monitor, a display device. IVDs are typically instruments, reagents, or kits used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic results based on laboratory analysis.
Therefore, the CDL2119A (CCL352i2) monitor is a medical device used for displaying medical images, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) 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
CDL2119A (CCL352i2) is a 20.8-inch (53cm) 3 megapixel color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) 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)
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
K072065
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan | AUG 14 2007 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Mikio Hasegawa, General Manager
Email: hasegawam@totoku.co.jp
Tel:+81.268.34.5469
Fax:+81.268.34.5548 | |
| Date Prepared: | July 24, 2007 | |
| Device Name: | 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2) | |
| Common Name: | CDL2119A, CCL352i2 | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 3M Color LCD Monitor CCL350i (CDL2112A) (DV3MC-HB)
(K050619) | |
| Device Description: | CDL2119A (CCL352i2) is a 20.8-inch (53cm) 3 megapixel color
LCD monitor that supports DVI video signal and provides UXGA
(1536 x 2048) resolution for both landscape and portrait display. | |
| Indended Use: | 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2) is
intended 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: | CDL2119A (CCL352i2) shares the same characteristics with our
predicate device CCL350i (CDL2112A) (DV3MC-HB) (K050619)
except for a LCD panel, power supply and (additional) fan. | |
1
Image /page/1/Picture/0 description: The image shows a circular seal with the words "U.S. Department of Health & Human Services" written around the edge. In the center of the seal is a stylized image of an eagle with three lines extending from its wing. The seal is black and white and appears to be a scan of a printed document.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K072065
Trade/Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2007 Received: July 27, 2007
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 shows a circular logo with the text "1906-2006" at the top. Below this text is a large "FDA" abbreviation. The word "Centennial" is written below the abbreviation. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
2
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 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 Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Healt
Enclosure
3
K072065 INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) Indications for Use:
20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) 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)
Thhang
Division of Reproductive. Abdominal a Radiological Devices 510(k) Number