(47 days)
Not Found
No
The 510(k) summary describes a medical monitor for displaying images and does not mention any AI or ML capabilities.
No
The device is a medical display monitor used for viewing medical images for diagnosis, not for treating any medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners." This explicitly defines its use in the diagnostic process.
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 that the device is for "displaying and viewing medical images for diagnosis by trained medical practitioners." This describes a device used to visualize images generated by other medical devices (like X-rays, CT scans, etc.).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This monitor does not perform any such tests.
- Device Description: The description details a monitor, which is a display device, not a device that analyzes biological samples.
Therefore, the CCL258i2 (CL21258) monitor falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL258i2 (CL21258) 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
CCL258i2 (CL21258) 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)
The overall design of the CCL258i2 (CL21258) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL258i2 (CL21258) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
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
K133181
Page 1 of 4
510(k) SUMMARY
DEC 0 3 2013
| Submitted Information: | JVC KENWOOD CORPORATION
3-12, MORIYA-CHO, KANAGAWA-KU,
YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, General Manager
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | October 4, 2013 |
| Device Name: | 21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258) |
| Common Name: | CCL258i2, CL21258 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Col or LCD Monitor CCL25 6i2 (CL21256)
(K113136) |
| Device Description: | CCL258i2 (CL21258) 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, CCL258i2 (CL21258)
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: | CCL258i2 (CL21258) shares the same characteristics with our
predicate device CCL256i2 (K113136) except for the LCD panel
and power supply. |
1
| Technical Specification | |
|---|---|
| 1. Luminance uniformity | |
| [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance | |
| uniformity data | |
| 2. Pixel Defects / Fault | |
| [SPEC] Class II or more. ISO13406-2 | |
| 3. Artifacts | |
| • phase/clock issues flicker | |
| • miscellaneous including ringing, ghosting, image sticking | |
| [SPEC] By visible check, no flicker, ringing, ghosting and image sticking | |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | |
| [SPEC] data | |
| 5. Chromaticity | |
| [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 | |
| Refer to Chromaticity actual data |
・
.
:
2
Substantial Equivalence Comparison
| 510(k) Number | CCL256i2 (CL21256) | CCL258i2 (CL21258) |
|---|---|---|
| Display Area | K113136 | |
| Horizontal: 432.0mm, Vertical: 324.0mm | K133181 | |
| Horizontal: 432.0mm, Vertical: 324.0mm | ||
| Input Signal | DVI-D Digital Video Signal, DisplayPort | DVI-D Digital Video Signal, DisplayPort |
| Maximum Display | 1200 x 1600 dots | 1200 x 1600 dots |
| Pixel Pitch | 0.270 x 0.270 mm | 0.270 x 0.270 mm |
| Scanning Frequency | DVI | |
| 74.1KHz, Vertical: 60Hz (Landscape) | ||
| 98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 75.0KHz, Vertical: 60Hz (Landscape) | ||
| 99.0KHz, Vertical: 60Hz (Portrait) | DVI | |
| 74.1KHz, Vertical: 60Hz (Landscape) | ||
| 98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| 75.0KHz, Vertical: 60Hz (Landscape) | ||
| 99.0KHz, Vertical: 60Hz (Portrait) | ||
| Maximum Luminance | 410 cd/m² DICOM calibrated | |
| 950 cd/m² typ.as LCD component | 410 cd/m² DICOM calibrated | |
| 900 cd/m² typ.as LCD component | ||
| Luminance Calibration | ||
| (Optional) | Software: Medivisor Nx | |
| Calibration Sensor (Optional): Chroma5 (X-Rite) | Software: Medivisor Nx | |
| Calibration Sensor (Optional): Chroma5 (X-Rite) | ||
| Contrast Ratio | 900:1 | 1400:1 |
| Serial Communication | USB: upstream port (x 1), downstream port (x 2) | USB: upstream port (x 1), downstream port (x 2) |
| Safety Standards | Medical: UL60601-1, CSA C22.2 No.601.1, FCC (Class B), | |
| MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) | |
| Weight & Dimension | Net: 12kg | |
| 474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape) | ||
| 367(w) x 521.9 - 583.4(H) x 220(D) mm (Portrait) | ||
| Packed: 15.0kg | ||
| 470(w) x 670(H) x 345(D) mm | Net: 12kg | |
| 474(w) x 468.4 - 529.9(H) x 220(D) mm (Landscape) | ||
| 367(w) x 521.9 - 583.4(H) x 220(D) mm (Portrait) | ||
| Packed: 15.0kg | ||
| 470(w) x 670(H) x 345(D) mm | ||
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
Samples
Similarities:
CCL258i2 (CL21258) employs the same front bezel, back enclosure and tilt stand as predicate device CCL256i2 (K113136)
Differences
Differences:
Differences:
CCL258i2 (CL21258) employs a different LCD panel and power supply.
3
KB33181
page 4 of 4
CCL258i2 (CL21258) can be considered to have equivalent display performances to those of the predicate device CCL256i2 (K113136) due to the following reasons:
- a. The maximum display sizes (1600*1200) and the active area sizes (432.0mm (H) x 324.0mm (V)) used for the both devices are the same.
- b. The DICOM calibrated luminance values of the both devices are the same (410 cd/m2) though the typical maximum luminance value (900 cd/m2) is lower than that of the predicate device (950 cd/m2). The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- c. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to "Technical Data" where several image quality characteristics of the proposed device are compared with those of the predicate device.
- d. The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in lookup tables inside of them.
- e. Both devices support Digital Visual Interface (DVI) and DisplayPort.
As for the maintenance, the same QC software is used for both devices. Both devices have Front Sensor to stabilize the luminance.
As for built-in sensors, both devices have 2 (two) kinds of common sensors, Front Sensor and Ambient Light Sensor. Front Sensor is related to the maintenance or calibration and Ambient Light Sensor is used to measure the ambient light by lx. Front sensor enables automatic grayscale calibration by measuring the luminance at the screen surface. Without Front sensor, the grayscale calibration process requires human intervention and the use of and external sensor. The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 "Verification & Validation" in "Application".
The overall design of the CCL258i2 (CL21258) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL258i2 (CL21258) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Color LCD Monitor, CCL258i2 (CL21258) is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are the same to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2013
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi. Kanagawa. 221-0022 JAPAN
Re: K133181
Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL258i2 (CL21258) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 4, 2013 Received: October 17, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2-Mr. Tashiro
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sm.h.7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) KI33181
Device Name CCL258i2 (CL21258)
Indications for Use (Describe)
21.3 inch (54 cm) Color 2M pixel 1.CD Monitor CC1.258) 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 manmography.
Type of Use (Select one or both, as applicable)
[図] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
FORM FDA 3881 (9/13)
PSC Publicions Service (114) ; d 1-47 41 EF