(42 days)
No
The summary describes a medical monitor and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is a monitor used for medical imaging applications (PACS) and does not directly provide therapy. Its function is display, not therapeutic intervention.
No
The device is described as a color LCD monitor used in conjunction with a PACS for medical imaging applications. It is a display device, not a device that processes or analyzes medical data to make a diagnosis.
No
The device description explicitly states it is a "21.3-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 "medical imaging applications" in conjunction with a PACS system. This involves displaying medical images, which is an in vivo (within the living body) diagnostic process, not an in vitro (outside the living body) diagnostic process.
- Device Description: The description details a monitor, which is a display device. IVD devices are typically instruments, reagents, or kits used to examine specimens (like blood, urine, or tissue) in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or any other activity associated with in vitro diagnostics.
Therefore, the CDL2113A (CCL250i) (DV2MC-HB) is a medical device used for displaying medical images, not an IVD.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) 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
21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) is a 21.3-inch Color LCD Monitor that supports DVI video signal and provides UXGA (1600 x 1200) 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
APR 2 1 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: March 7, 2005
21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) Device Name:
Common Name: CDL2113A, CCL250i, DV2MC-HB, 2M Monitor/Display
-
Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: CDL2107A (K040697) -
CDL2113A (CCL250i) (DV2MC-HB) is a 21.3-inch Color LCD Monitor that Device Description: supports DVI video signal and provides UXGA (1600 x 1200) resolution for both landscape and portrait display.
- 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) is to Intended Use: 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.
-
CDL2113A (CCL250i) (DV2MC-HB) has almost the same characteristics as Substantial Equivalence: TOTOKU's predicate device CDL2107A (K040697) except for the molds and the front sensor, which has been newly placed.
CDL2113A Premarket Notification
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wings and body. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K050616 Trade/Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems ﺎ Regulatory Class: II Product Code: LLZ Dated: March 7, 2005 Received: March 10, 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 the cholors') to regary mant date of the Medical Device Amendments, or to devices that have been rear 20, 1770, are cance 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 do not require approval controls provisions of the Act. The general controls provisions of the Act de nee, subject to the genual 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 11 your de read it a such additional controls. Existing major regulations affecting your Apployal), It ifal 700 books 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 I loase or devised 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 I cara suiteres and regularing, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modeling practice requirements as set forth in the quality systems (QS) (21 CFR Part 80 7) good million 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 0 local i his letter will anow you to ocgin maneting of substantial equivalence of your device to a legally premarket notification. The PDA moning of Sacstantial vijas and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire spective advice for your device on our lacenting org 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 prematic notification the Act frem the Also, please note the regulation entitled, "Thisoration on your responsibilities under the Act from the 807.97). You may obtain other general information of the summer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address 056-2011-01-01-25 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 .
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1010
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-HB). Indications for use:
21.3-inch (54cm) Color LCD Monitor CDL2113A (CCL250i) (DV2MC-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)
Nancy Broaddus
IDivision Sign-Division of Reproduc and Radiological Devices 510(k) Number