(57 days)
Not Found
No
The document describes a medical display monitor and does not mention any AI or ML capabilities.
No
The device is described as an LCD monitor intended for displaying and viewing medical images for diagnosis, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners." This directly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "21.3-inch (54 cm) 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 is to display and view medical images for diagnosis. This involves interpreting images generated by other medical devices (like X-rays, CT scans, etc.), not performing tests on biological samples.
- Device Description: The device is a monitor, a display technology. IVD devices are typically instruments, reagents, or kits used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing information about a patient's health status based on laboratory tests.
Therefore, the CCL256i2 (CL21256) monitor is a medical device used for displaying diagnostic images, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL256i2 (CL21256) 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 (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
TOTOKU
.
510(k) SUMMARY
DEC 2 0 2011
| Submitted Information: | TOTOKU ELECTRIC CO., LTD.
300 Oya, Ueda
Nagano 386-0192 Japan |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager
Email: tasirot@totoku.co.jp
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | October 21, 2011 |
| Device Name: | 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256) |
| Common Name: | CCL256i2, CL21256 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Color LCD Monitor CCL254i2 (CDL2125A)
(K081055) |
| Device Description: | CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor
whose display resolution is 1200 x 1600 (landscape), 1600 x 1200
(portrait) supporting DVI (digital visual interface) and Display Port. |
| Intended Use: | 21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL256i2 (CL21256)
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: | CCL256i2 (CL21256) shares the same characteristics with our
predicate device CCL254i2 (K081055) except for the power supply. |
TOTOKU ELECTRIC CO., LTD. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 Japan
1
Image /page/1/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr.Tsukasa Tashiro General Manager TOTOKU Electric Co., LTD 300 Ova 386-0192 UEDA NAGANO JAPAN
DEC 2 0 2011
Re: K113136
Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 21, 2011 Received: October 24, 2011
Dear Mr. Tashiro:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
:510(k) Number (if known):_K113136
Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256)
Indications for Use:
21.3 inch (54 cm) Color 2M pixel LCD Monitor CCL256i2 (CL21256) is intended 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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Muhal D. Jha
Office of In Vit
ETOK
Page 1 of ____________________________________________________________________________________________________________________________________________________________________