(51 days)
No
The summary describes a medical monitor for displaying images, with no mention of AI/ML features or image processing capabilities beyond basic display functions.
No
This device is a medical image display monitor used for diagnosis, not for treating any condition.
No
The device is a monitor used for displaying medical images; it does not perform diagnosis itself.
No
The device description explicitly states it is a "21.3-inch (54cm) 2 megapixel 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:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a medical monitor used for displaying and viewing medical images. It is a display device, not a device that analyzes biological samples.
The intended use clearly states it's for "displaying and viewing medical images," which is a function of medical imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is intended 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
CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) 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
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)
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
08/055
JUN - 4 2008
: : :
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:+81.268.34.5548 | |
| Date Prepared: | March 17, 2008 | |
| Device Name: | 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) | |
| Common Name: | CCL254i2, CDL2125A | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 2M Color LCD Monitor CDL2120A (CCL252i2) (K063199) | |
| Device Description: | CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color
LCD monitor that supports DVI video signal and provides UXGA
(1200 x 1600) resolution for both landscape and portrait display. | |
| Intended Use: | 21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is
intended 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. | |
| Substantial Equivalence: | CCL254i2 (CDL2125A) shares the same characteristics with our | |
predicate device CCL252i2 (CDL2120A) (K063199) except for power supply, front bezel, frame, fan, PCB and LCD screen.
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K081055
Trade/Device Name: 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 2, 2008 Received: April 14, 2008
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 (PMA), 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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Bragdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) Indications for Use:
21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in 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)
Vorzu Th Whay
(Division S Division of Reproductive, Abdominal and Radiological Devices 510(k) Number