(35 days)
Not Found
No
The 510(k) summary describes a standard medical monitor and does not mention any AI or ML capabilities.
No
The device is a medical monitor used for displaying medical images, not for providing therapy or treatment.
No
The device is a medical monitor used for displaying medical images, but it doesn't perform diagnostic functions itself. It's explicitly stated to be used "in conjunction with the picture archiving communication system (PACS) for medical imaging applications," and a diagnostic device would typically involve some form of analysis, interpretation, or decision support, which is not described here.
No
The device description explicitly states it is a "19-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 clearly states it's a monitor for medical imaging applications in conjunction with a PACS system. This is a display device for viewing medical images, not a device that performs tests on biological samples to diagnose conditions.
- Device Description: The description details the technical specifications of a monitor (size, resolution, scanning function). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic algorithms based on biological markers
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.)
Therefore, the CDL1902A (CCL192 plus) monitor is a medical device used for displaying medical images, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Product codes
LLZ
Device Description
CDL1902A (CCL192 plus) is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
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
Not Found
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)
ME183L (K030272)
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
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: +81.268.34.5565
Date Prepared: May 20, 2005
-
19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) Device Name:
CDL1902A, CCL192plus, 1.3M Monitor/Display Common Name: -
Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: ME183L (K030272) -
Device Description: CDL1902A (CCL192 plus) is a 19-inch Color LCD Monitor that has a multi-scanning function corresponding to resolution from VGA 640 x 400 to SXGA 1280 x 1024. This is also compliant with VESA standard display mode.
- Intended Use: 19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
-
CDL1902A (CCL192 plus) has almost the same characteristics as TOTOKU's Substantial Equivalence: predicate device ME183L (K030272) except for the panel, molds and boards.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three stripes above it. The bird is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., LTD. MM Company, Design Group 300 Oya, Ueda, Nagano, 386-0192 JAPAN
Re: K051331 Trade/Device Name: 19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 Plus) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2005 Received: May 23, 2005
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.
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.
JUN 2 7 2005
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket nothication. The I Dri mainly of bactification 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 advice for your corres on our of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation cinnition, "First and on your responsibilities under the Act from the 807.97). You may obtain outcr general internation on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
TOTOKU
INDICATIONS FOR USE
510(k) Number: Not Known Device Name: 19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus). Indications for use:
19-inch (48cm) Color LCD Monitor CDL1902A (CCL192 plus) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use V (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
(Division Sign-Off
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051331
TOTOKU ELECTORIC CO., LTD