(44 days)
ME183L (K030272)
Not Found
No
The document describes a standard LCD monitor for medical imaging and contains no mention of AI or ML technologies.
No
The device is a monitor used for displaying medical images and does not have a direct therapeutic function.
No
The device is a medical monitor used for displaying images from a PACS system, not for making a diagnosis itself. It is a display tool, not a diagnostic one.
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 the monitor is for use with a PACS system for medical imaging applications. This involves displaying medical images, which is a function related to medical diagnosis but not through the examination of specimens derived from the human body.
- Device Description: The description details a monitor with display capabilities, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening based on specimen analysis.
Therefore, the CDL1904A 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
19-inch (48cm) Color LCD Monitor CDL1904A 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
CDL1904A 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
TOTOKU
JUL 1 4 2005
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 27, 2005 |
| Device Name: | 19-inch (48cm) Color LCD Monitor CDL1904A |
| Common Name: | CDL1904A, 1.3M Monitor/Display |
| Classification Name: | Class II
(Part892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | ME183L (K030272) |
| Device Description: | CDL1904A 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 CDL1904A 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. |
Substantial Equivalence: CDL1904A has almost the same characteristics as TOTOKU's predicate device ME183L (K030272) except for the panel, molds and boards.
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/1/Picture/11 description: The image shows a black and white logo. The logo features a circular border with text around the edge. Inside the circle is a symbol consisting of three curved lines that resemble stylized human figures or abstract shapes. The overall design is simple and iconic.
JUL 1 4 2005
Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 JAPAN
Re: K051403 Trade/Device Name: 19-inch (48cm) Color LCD Monitor CDL1904A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 27, 2005 Received: May 31, 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 Apple rary, it ifal of ot begilations, 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 5 I (k) This letter will allow you to begin mancelig your antial equivalence of your device to a legally premarket notification. The FDA Inding of sabstantial of a more of the system of this, 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 device on our laboring regarded 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 entities, "Ansolution on your responsibilities under the Act from the 807.97). You may obtain other general mionnation on Jour Copyright DIVISION or (301) 443-6597 or at its Internet address
056-2017 of (2 gov/cdrh/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
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TOTOKU
INDICATIONS FOR USE
510(k) Number: Not Known Device Name: 19-inch (48cm) Color LCD Monitor CDL1904. Indications for use:
19-inch (48cm) Color LCD Monitor CDL1904A is to be used in conjunction with the 19-lich (10cm) Color 2016) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
(Part 21 CFR 801 Subpart D)
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 C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 51()(k) Number
R