(59 days)
Not Found
No
The summary describes a medical monitor and does not mention any AI or ML capabilities.
No
The device is a medical image display monitor used for viewing images, not for actively treating a condition or disease.
Yes
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 identifies its role 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the CCL214 (CL21214) is a monitor intended for displaying and viewing medical images. It does not perform any tests on biological samples.
- Intended Use: The intended use is for diagnosis by trained medical practitioners based on the visual interpretation of images, not through the analysis of in vitro samples.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
2MP Color LCD Monitor CCL214 (CL21214) 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.
Product codes
PGY
Device Description
CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).
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)
JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12, Moriya-cho, Kanagawa-ku Yokohama. Kanagawa 221-0022 JAPAN
Re: K161895
Trade/Device Name: 2MP Color LCD Monitor CCL214 (CL21214) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 8, 2016 Received: July 11, 2016
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
2MP Color LCD Monitor CCL214 (CL21214)
Indications for Use (Describe)
2MP Color LCD Monitor CCL214 (CL21214)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku,
Yokohama-shi, Kanagawa, 221-0022 Japan |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, Engineering Specialist
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81-258-24-6611
Fax: +81-258-24-6617 |
| Date Prepared: | July 08, 2016 |
| Device Name: | 2MP Color LCD Monitor CCL214
(CL21214) |
| Common Name: | CCL214 (CL21214) |
| 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 CCL210 (CL21210)
(K151134) |
| Device Description: | CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor
whose display resolution is 1600 x 1200 (landscape), 1200 x 1600
(portrait) supporting DVI-D (digital interface) and DisplayPort
(digital interface). |
| Intended Use: | 21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL214
(CL21214) 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. |
| Substantial Equivalence: | CCL214 (CL21214) shares the same technical characteristics,
application, and intended use as our predicate device CCL210
(CL21210 / K151134). |
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| Technical Specification |
|---|
| 1. Luminance uniformity |
| [SPEC] Less than 30% based on AAPM-TG18 4.4. |
| 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 |
| 5. Chromaticity |
| [SPEC] Delta (u', v') $\leq$ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 6. Power On Luminance Drift |
| [SPEC] $\triangle$ Lmax≤±10% within 60 seconds. |
| $\triangle$ Lmax : the deviation between the target maximum luminance and the measured luminance. |
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| CCL210 (CL21210) | CCL214 (CL21214) | |
|---|---|---|
| 510(k) Number | K151134 | Not Known |
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm | Horizontal: 432.0mm, Vertical: 324.0mm |
| Input Signal | DVI-I 29-pin connector, DisplayPort connector | DVI-D 24-pin connector, DisplayPort connector |
| Maximum Resolution | 1200 x 1600 at portrait display | |
| 1600 x 1200 at landscape display | 1200 x 1600 at portrait display | |
| 1600 x 1200 at landscape display | ||
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm |
| Scanning Frequency | Horizontal: 30 - 75kHz | |
| Vertical: 55 - 60Hz | DVI | |
| Horizontal: 74.1KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:98.1KHz, Vertical: 60Hz (Portrait) | ||
| DisplayPort | ||
| Horizontal: 75.0KHz, Vertical: 60Hz (Landscape) | ||
| Horizontal:99.0KHz, Vertical: 60Hz (Portrait) | ||
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 250 cd/m² DICOM calibrated | |
| 440 cd/m² typ. As LCD component | 250 cd/m² DICOM calibrated | |
| 500 cd/m² typ. As LCD component | ||
| Luminance Calibration | ||
| (Optional) | Software | |
| Photo Sensor (optional): X-Rite Chroma 5 | Software | |
| Photo Sensor (optional): X-Rite i1 Display | ||
| Contrast Ratio | Typ 1500:1 | Typ 1200:1 |
| Serial Communication | USB | USB |
| Safety Standards | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 | |
| No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), | ||
| ICES-003 (Class B) | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 | |
| No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), | ||
| ICES-003 (Class B) | ||
| Weight & Dimension | Net: 10.7kg | |
| 473(w) x 476.4 – 537.9(H) x 220(D) mm | ||
| Packed: 15.5kg | ||
| 470(w) x 675(H) x 347(D) mm | Net: 11.1kg | |
| 367.0(w) x 521.9 – 583.4(H) x 220(D) mm | ||
| Packed: Approx.14.0kg | ||
| 470(w) x 670(H) x 340.0(D) mm | ||
| Power Supply | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz |
antial Equivalence Compa
The LCD panel, the power supply, and the main board for CCL214 (CL21214) are different from those for CCL210 (Predicati
device). Differences
tilt stand for CCL214 (CL21214) is the same as CCL210 (K151134).
the sizes of front bezel and the rear cover are smaller than ones of CCL210 only sli Similarities:
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CCL214 (CL21214) can be considered to have equivalent performances to those of the predicate device CCL210 (K151134) due to the following reasons:
- a. CCL214 (CL21214) and the predicate device CCL210 (K151134) have the same active area whose size is 432.0mm x 324.0mm. Also, the maximum display resolution for both models is 1600 x 1200.
- b. As for the maximum luminance, CCL214 (CL21214) is superior to CCL210 (K151134). (CCL214 (CL21214): 500cd/m2 and CCL210 (K151134):440cd/m2) The maximum luminance by DICOM calibration at the factory default is 250cd/m2 for both CCL214 (CL21214) and the predicate device CCL210 (K151134).
- The LED backlight is equipped with CCL214 (CL21214) and the predicate device ﻥ CCL210 (K151134).
- As the factory default status, the both devices display images in accordance with DICOM ರ. GSDF which is stored in the lookup table inside the device.
- e. CCL214 (CL21214) supports DVI and DisplayPort as well as the predicate device CCL210 (K151134) .
As for the maintenance, the same QC software is used for both devices. CCL210 (K151134) has the backlight sensor to stabilize the luminance, but CCL214 (CL21214) has the front luminance sensor, which means the higher performance, to do so.
The overall design of the CCL214 (CL21214) has been validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance.
Conclusion
The 2M pixel Color LCD Monitor, CCL214 (CL21214) is substantially equivalent to the predicate device with respect to technical characteristics, its application, its intended use, and the specifications of the primary components.
And other differences have been independently validated.
But any differences between these two devices do not affect safety or effectiveness.