(85 days)
Not Found
No
The 510(k) summary describes a medical imaging monitor and does not mention any AI or ML capabilities. The description focuses on the display technology and its performance characteristics.
No.
The device is a monitor used for displaying medical images and does not provide any treatment or therapy to a patient.
No
The device is a medical imaging monitor used in conjunction with PACS for medical imaging applications. Monitors display images; they do not diagnose.
No
The device description explicitly states it is a "21.3-inch (54cm) 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 clearly states it's a monitor for medical imaging applications in conjunction with PACS. It displays images generated by other medical devices (like CT and MRI).
- Device Description: It describes a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This monitor's function is to display images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) 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
Best suited for CT and MRI, CCL212 (CDL2107A) is a 21.3-inch high definition color medical imaging LCD monitor with higher luminance (450cd/m²) and longer lifetime (three times as long as our existing models). With circuit, mounted, CCL212 (CDL2107A) delivers stable display of images.
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)
CDL2005A (K021738)
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
Kø4@697
510(k) SUMMARY JUN 1 0 2004
TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Nagano 386-0192 Japan
- Mikio Hasegawa, General Manager Contact Person: Email: haseqawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548
- March 15, 2004 Date Prepared:
- 21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) Device Name:
- Common Name: CCL212, CDL2107A, 2M Monitor/Display
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- CDL2005A (K021738) Predicate Device:
- Best suited for CT and MRI, CCL212 (CDL2107A) is a 21.3-inch Device Description: high definition color medical imaging LCD monitor with higher luminance (450cd/m²) and longer lifetime (three times as long as our existing models). With circuit, mounted, CCL212 (CDL2107A) delivers stable display of images.
- Indended Use: 21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) 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.
- Substantial Equivalence: CCL212 (CDL2107A) shares the same characteristics with our predicate device CDL2005A (K021738) except for the panel which is superior to the predicate device in display area, luminance, and number of photo sensors and serial communication connectors available. It also has a three-times longer lifetime.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2004
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. MM Company, design Group 300 Oya, Ueda Nagano 386-0192 JAPAN
Re: K040697 Trade/Device Name: 21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 15, 2004 Received: March 17, 2004
Dear Mr. Hasegawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications ferenced above and nave coloring gally marketed predicate devices marketed in interstate Ior use stated in the enorosary to togally to togal .
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 20, 1125 20, 1125 20, 2017 11:25 provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). and Costiere rior (110) that be nevice, subject to the general controls provisions of the Act. The I ou may, therefore, market and as tees) and include requirements for annual registration, listing of general bonnels provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classinod (500 a0070) als. Existing major regulations affecting your device can thay be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be round in the Obouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Driv issuales of our device complies with other requirements of the Act that I DA has made a decermnaulations administered by other Federal agencies. You must comply or any I cacrares and regenderag, but not limited to: registration and listing (21 CFR Part with an the 710- 1 requirements) in good manufacturing practice requirements as set forth in the 6017; laborang (21 CFR Part 820); and if applicable, the electronic product quality Systems (QD) . cyclinis (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) I ms letter will anow you to begin harteang your device of your device of your device to a legally premarket notification. The PDA misms of casion for your device and thus, permits your device
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your down to the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the problem Also, please note the regulation entitled, "Misbranding Other of Compliano at (301) 97 - 185 (21CFR Part 807.97) you may obtain. Other general by recreation on your responsibilities under the Act may be obtained from the Division of Small mornlation on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or 1401) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. B Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
to proceed to the market.
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INDICATIONS FOR USE
1544697 510(k) Number: Not Known Device Name: 21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) Indications for Use:
21.3-inch (54cm) Color LCD Monitor CCL212 (CDL2107A) 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)
David A. Leggans
Division Sian-Off and Radiological Devic 510(k) Number