(46 days)
Not Found
No
The document describes a medical monitor and does not mention any AI or ML capabilities.
No.
The device is a monitor used to display medical images and is not directly involved in treating or diagnosing diseases.
No.
The device is a monitor used for displaying medical images, not for making diagnostic interpretations or analyses.
No
The device description clearly 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 clearly states it's for use with PACS for medical imaging applications. This involves displaying medical images, which is a different function than an IVD.
- Device Description: The description details a monitor, which is a display device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This monitor's function is to display images generated by other medical devices.
N/A
Intended Use / Indications for Use
20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) 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.
Product codes
90 LLZ
Device Description
CDL2114A (DV3MC-HB) is a 20.8-inch color LCD monitor that supports a DVI video signal and provides QXGA (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
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)
CCL316 (K032555)
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
JAN 2 8 2005
510(k) SUMMARY
- TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5484 Fax: +81.268.34.5565
Date Prepared: December 10, 2004
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20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) Device Name:
CDL2114A, DV3MC-HB, 3M Monitor/Display Common Name: -
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
CCL316 (K032555) Predicate Device: -
CDL2114A (DV3MC-HB) is a 20.8-inch color LCD monitor that Device Description: supports a DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
- 20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) is to Indended Use: 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.
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CDL2114A (DV3MC-HB) is almost the same characteristics as Substantial Equivalence: TOTOKU's predicate device CCL316 (K032555) except for the LCD panel, which is brighter and has longer lifetime, and the AC adapter, which has higher capacity.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2005
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K043430 Trade/Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 10, 2004 Received: December 16, 2004
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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organization of substantial equivalence of your device to a legally premaired nothleation: "The PDF mailing of vour 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 active as one 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 Allot, process nother general information on your responsibilities under the Act from the 807.77). " Ou may obtain Jurers, International and Consumer Assistance at its toll-free number (800) DVNSloll or 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
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INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) Indications for Use:
20.8-inch (53cm) Color LCD Monitor CDL2114A (DV3MC-HB) 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 _ (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)
Yancy C. Brogdon
(Division Sign-Division of Reproductive, Abdom and Radiological Devices 510(k) Number