(90 days)
CCL650i2 (CL30650/ K140214)
Not Found
No
The description focuses on the monitor's display technology, calibration, and image uniformity features, with no mention of AI or ML for image analysis or processing.
No
The device is a medical display monitor for viewing medical images, not for providing therapy.
No
This device is a medical image display monitor (similar to a computer screen) intended for viewing medical images, not for diagnosing conditions or processing diagnostic information. Its functions are related to image display quality and stability, not diagnostic interpretation.
No
The device description explicitly states it is a "30 inch Color LCD Monitor" and details hardware components like the LCD panel, luminance sensor, and control circuit. It also describes physical laboratory tests related to hardware performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying and viewing medical images". This is a function related to presenting diagnostic information, but not to performing a diagnostic test on a biological sample.
- Device Description: The description focuses on the technical specifications of a monitor designed for displaying medical images (luminance, grayscale characteristics, uniformity). It doesn't describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Measurement of analytes
- Providing a diagnostic result based on sample analysis
The device is a medical image display monitor, which is a component used in the process of interpreting diagnostic images, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
CL-S600 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
30 inch Color LCD Monitor 3280 x 2080 (landscape)
- High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
- Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
- Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
- Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
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 or certified personnel.
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)
Physical Laboratory Tests were performed for performance test items in the guidance:
a. Spatial resolution. Test method: The bar pattern is displayed and captured by a digital camera equipped with a macro lens. The MTF is calculated with the captured data.
b. Pixel defects (maximum counts, allowed defect types, and locations). Test methods: ISO 13406-2, IDMS 1.03, 7.6 DEFECTIVE PIXELS. Pixel defects are counted based on the ISO13406-2, 3.4.13 table 3.
c. Artifacts. Test methods: AAPM-TG18, 4.9 Miscellaneous Tests, IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES.
d. Temporal response. Test methods: IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME. Rise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by the panel manufacturer.
e. Luminance (maximum, minimum, achievable, and recommended). Test method: $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed.
f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF). Test method: AAPM-TG18, 4.3.5 Advanced Luminance Response. Luminance response for 256 levels are measured.
m. Color tracking (primary colors and color gamut). Test methods: Color scale: IDMS 1.03, 6. Gray- and Color-Scale Measurement; IDMS 1.03, 5.4 Color-Signal White; Color gamut volume: IDMS 1.03, 5.31 Volume-Color-Reproduction Capability.
n. Gray tracking (gray shades and white point). Test methods: AAPM-TG196 Gray Tracking; IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation.
Key results: The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device.
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.
CCL650i2 (CL30650/ K140214)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
December 16, 2021
Re: K212985
Trade/Device Name: 6MP Color LCD Monitor CL-S600 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: September 27, 2021 Received: September 30, 2021
Dear Hideki Tengeiji:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212985
Device Name 6MP Color LCD Monitor CL-S600
Indications for Use (Describe)
CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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: JVCKENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan Contact Person: Hideki Tengeiji, Senior Manager Email: tengeiji.hideki@jvckenwood.com Tel: +81-45-450-2715 Fax: +81-45-450-1926 Date Prepared: September 14, 2021 6MP Color LCD Monitor CL-S600 Device Name: Common Name: display, diagnostic radiology Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Medical Image Management and Processing System 30 inch (76.8cm) Color LCD Monitor CCL650i2 Predicate Device: (CL30650/ K140214) Device Description: 30 inch Color LCD Monitor 3280 x 2080 (landscape) ■ High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. ■ Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. ■ Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. ■ Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
JVCKENWOOD Corporation
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JVCKENWOOD
| Cybersecurity: | FDA guidance located at
https://www.fda.gov/media/86174/download, is followed for
cybersecurity concerns. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | CL-S600 is intended to be used in displaying and viewing medical
images for diagnosis by trained medical practitioners or certified
personnel. It is not meant to be used in digital mammography. |
| Substantial Equivalence: | CL-S600 shares the same technical characteristics, application,
and intended use as our predicate device CCL650i2
(CL30650/ K140214) |
JVCKENWOOD Corporation
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Device Description & Substantial Equivalence Comparison
| | Predicate device
LCD Monitor CL30650 | Proposed device
LCD Monitor CL-S600 | Explanation of
Differences |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K140214 | - | - |
| Indication for use | CL30650 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. | CL-S600 is intended to be used in
displaying and viewing medical images for
diagnosis by trained medical practitioners
or certified personnel. It is not meant to be
used in digital mammography. | - |
| Display Technology | IPS LCD panel with TFT active-matrix
array with LED backlight | IPS LCD panel with TFT active-matrix
array with LED backlight | - |
| Screen size | Diagonal: 30"
Aspect ratio: 16:9.99 | Diagonal: 30"
Aspect ratio: 16:10.15 | The display area of the proposed device is
wider than the predicate device.
Compared to the predicate device, the
proposed device has a larger display area. |
| Backlight type | LED | LED | - |
| Frame rate and refresh
rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 6MP (3280 x 2048) | 6MP (3280 × 2080) | The resolution of the proposed device is
larger than that of the predicate device. |
| Pixel Pitch | Horizontal: 0.197mm
Vertical: 0.197mm | Horizontal: 0.197mm
Vertical: 0.197mm | - |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 43.0% | 46.5 % | Almost the same. |
| Subpixel driving (spatial
and temporal dithering) | N/A | N/A | - |
| Display Interface | Input:
DVI-D x2
DisplayPort x2
Output:
N/A | Input:
DisplayPort x2
Output:
DisplayPort x1 | The proposed device is not equipped with
a DVI-D input, but this is not a problem
since graphics cards are no longer
equipped with a DIV-D output. |
| Video bandwidth | Dot clock: 443.52 MHz | Dot clock: 443.52 MHz | - |
| | Predicate device
LCD Monitor CL30650 | Proposed device
LCD Monitor CL-S600 | Explanation of
Differences |
| User controls | Input signal switch
EDID switch
Dynamic gamma
AUTO TEXT
Test pattern
Configuration switch,
INPUT SOURCE AUTO SCANNING | Input signal switch
Dynamic gamma
AUTO TEXT
Test pattern
Configuration switch
Pixel Enhancer
Turbo Luminance
Dynamic Range Extension
Auto Config Select
Human Presence Sensor
Reading Light
USB Power | The functions in the predicate device are
also available in the proposed device.
Regarding "EDID switch", the proposed
device can automatically switch EDID. |
| Ambient light sensing | Built-in Sensor (For correction during
calibration) | Built-in Sensor (For correction during
calibration) | - |
| Touch-screen
technology | N/A | N/A | - |
| Luminance calibration
tools / Quality-control
procedures | Hardware:
Integrated sensor
External sensor
Software:
QA Medivisor / Medivisor NX
FCAL | Hardware:
Integrated sensor
External sensor
Software:
QA Medivisor Agent
FCAL | - |
| Additional
Software/Firmware | N/A | N/A | - |
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Physical Laboratory Tests
| Performance test items in the guidance | Test method(s) |
|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital camera |
| equipped with a macro lens. The MTF is calculated with the | |
| captured data. | |
| b. Pixel defects (maximum counts, allowed | |
| defect types, and locations) | ISO 13406-2 |
| IDMS 1.03, 7.6 DEFECTIVE PIXELS | |
| Pixel defects are counted based on the ISO13406-2, 3.4.13 | |
| table 3. | |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests |
| IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES | |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME |
| Rise and fall time constants at four grayscale intervals (0-100%, | |
| 5-95%, 10-90%, 40-60%) are provided by the panel | |
| manufacturer. | |
| e. Luminance | |
| (maximum, minimum, achievable, and | |
| recommended) | $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed. |
| f. Conformance to a grayscale-to- | |
| luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response |
| Luminance response for 256 levels are measured. | |
| (For mammography displays) | |
| g. Luminance at 30° and 45° in diagonal, | |
| horizontal, and vertical directions at center | |
| and four corners | N/A |
| (For mammography displays) | |
| h. Luminance uniformity or Mura test | N/A |
| (For mammography displays) | |
| i. Stability of luminance and chromaticity | |
| response with temperature and time of | |
| operation or on-time | N/A |
| (For mammography displays) | |
| j. Spatial noise | N/A |
| (For mammography displays) | |
| k. Reflection coefficient | N/A |
| (For mammography displays) | |
| l. Veiling glare or small-spot contrast | N/A |
| (For color displays) | |
| m. Color tracking (primary colors and color | |
| gamut) | Color scale: |
| IDMS 1.03, 6. Gray- and Color-Scale Measurement | |
| IDMS 1.03, 5.4 Color-Signal White | |
| Color gamut volume: | |
| IDMS 1.03, 5.31 Volume-Color-Reproduction Capability | |
| (For color displays) | |
| n. Gray tracking (gray shades and white | |
| point) | AAPM-TG196 Gray Tracking |
| IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale | |
| chromaticity evaluation |
Conclusion
As shown above, the intended use of the subject and predicate devices are identical, the technical characteristics are similar, and any differences between the characteristics do not affect the device safety or effectiveness. The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device.