(24 days)
Not Found
No
The summary describes a medical monitor for displaying images and does not mention any AI/ML capabilities or related performance metrics.
No
The device is a monitor used for displaying medical images; it does not provide any therapeutic function or interact directly with the patient for treatment.
No
The device is a monitor used for displaying and viewing medical images for diagnosis, but it does not perform the diagnosis itself. Its function is display, not analysis or interpretation to identify disease.
No
The device description explicitly states it is a 15-inch high definition color medical imaging 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 that presents visual information to a medical practitioner, not a device that performs tests on biological samples to diagnose a condition.
- Device Description: The description focuses on the technical specifications of a monitor (size, resolution, luminance, contrast) and its intended use with an endoscope system. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of biomarkers or analytes
- Diagnostic tests performed on the device itself
The device is clearly a medical imaging display monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
15-inch (38cm) Color LCD Monitor CDL1566A 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
CDL1566A is a 15-inch high definition color medical imaging LCD monitor with high luminance (350cd/m² (typ.)) and high contrast screen (700:1 contrast ratio). Color LCD Monitor CDL1566A is to be used with FUJINON endoscope system, and is manufactured exclusive for FUJINON.
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)
CDL1904A (K051403)
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
Image /page/0/Picture/0 description: The image shows the word "TOTOKU" in a bold, sans-serif font. The letters are evenly spaced and appear to be printed in a dark color, possibly black or a dark gray. The background is plain and light, providing a clear contrast to the text.
510(k) SUMMARY
- Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Ova. 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: April 7, 2006
Device Name: 15-inch (38cm) Color LCD Monitor CDL1566A
- Common Name: CDL1566A
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: CDL1904A (K051403)
Device Description: CDL1566A is a 15-inch high definition color medical imaging LCD monitor with high luminance (350cd/m² (typ.)) and high contrast screen (700:1 contrast ratio). Color LCD Monitor CDL1566A is to be used with FUJINON endoscope system, and is manufactured exclusive for FUJINON.
- Indended Use: 15-inch (38cm) Color LCD Monitor CDL1566A 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 mammoqraphy.
- Substantial Equivalence: CDL1556A shares the same characteristics with our predicate device CDL1904A (K051403) except for the power supply, panel, and stand (optional).
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
1 2006 MAY
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 OYA, Ueda, Nagano, 386-0192 JAPAN
Re: K060961
Trade/Device Name: 15-inch (38cm) Color LCD Monitor CDL1566A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2006 Received: April 7, 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 shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. The words "Centennial" are written below the letters. The logo also contains the words "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.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 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 (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
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 15-inch (38cm) Color LCD Monitor CDL1566A Indications for Use:
15-inch (38cm) Color LCD Monitor CDL1566A 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 _ メ (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)
David R. Severson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Padinlogical Devices 510(k) Number