(101 days)
Not Found
No
The device description focuses on the hardware and display characteristics of a medical monitor, and there is no mention of AI, ML, or any software functionality that would suggest the use of these technologies for image analysis or processing beyond basic display calibration.
No
The device is a monitor used for displaying medical images for diagnosis, not for directly treating a medical condition.
No
This device is a medical monitor intended for displaying and viewing medical images for diagnosis, but it does not perform any diagnostic function itself. It is a display device, not a diagnostic device.
No
The device description explicitly states it is a "21.3 inch Color LCD Monitor" and details its hardware components and features, such as the LCD panel, luminance sensor, and control circuit.
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 for diagnosis". This is related to the interpretation of images, not the analysis of biological samples or substances from the body, which is the core function of an IVD.
- Device Description: The description focuses on the technical specifications of a medical monitor designed for displaying images. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Reagents or assays
- Calibration with biological standards
This device is clearly a medical image display monitor intended for use in the diagnostic process, but it does not perform the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
CL-S301 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
PGY
Device Description
21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
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
Yes
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 conducted, including:
- 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.
- 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.
- Artifacts: AAPM-TG18, 4.9 Miscellaneous Tests, IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES
- 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.
- Luminance (maximum, minimum, achievable, and recommended): Lmin and Lmax on the calibrated luminance are confirmed.
- 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.
- 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.
- Gray tracking (gray shades and white point): 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)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Jvckenwood Corporation Takayuki Kasahara Manager 3-12 Moriya-cho, Kanagawa-ku, Yokohama-shi Yokohama, Kanagawa 221-0022 Japan
Re: K241105
August 1, 2024
Trade/Device Name: 3MP Color LCD Monitor (CL-S301) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: July 5, 2024 Received: July 5, 2024
Dear Takayuki Kasahara:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb. Ph.D. Assistant Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
3MP Color LCD Monitor (CL-S301)
Indications for Use (Describe)
CL-S301 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.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| Submitted Information: | JVCKENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku,
Yokohama-shi, Kanagawa, 221-0022 Japan |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Takayuki Kasahara, Manager
Email: kasahara.takayuki@jvckenwood.com
Tel: +81-45-450-2715
Fax: +81-45-450-1926 |
| Date Prepared: | August 1, 2024 |
| Device Name: | 3MP Color LCD Monitor CL-S301 |
| Common Name: | display, diagnostic radiology |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050
Medical Image Management and Processing System |
| Product Code: | PGY |
| Predicate Device: | 21.3 inch Color LCD Monitor CL-S300
(CL-S300 / K173434) |
| Device Description: | 21.3 inch Color LCD Monitor
1536 x 2048 (portrait)
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. |
| Intended Use: | CL-S301 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. |
| Cybersecurity: | FDA guidance located at
https://www.fda.gov/media/119933/download, is followed for
cybersecurity concerns. |
| Substantial Equivalence: | CL-S301 shares the same technical characteristics, application,
and intended use as our predicate device CL-S300. |
JVCKENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022, Japan Tel +81-45-450-2715
JVCKENWOOD
4
(CL-S300 / K173434)
JVCKENWOOD Corporation 3-12, Moriya cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022, Japan
Tel +81-45-450-2715
JVCKENWOOD
5
Device Description & Substantial Equivalence Comparison
| | Predicate device
LCD Monitor CL-S300 | Proposed device
LCD Monitor CL-S301 | Explanation of
Differences |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K173434 | K241105 | - |
| Indication for use | CL-S300 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 | CL-S301 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: 21.3
Aspect ratio: 4:3 | Diagonal: 21.3
Aspect ratio: 4:3 | - |
| Backlight type | LED | LED | - |
| Frame rate and refresh
rate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 3MP (2048 x 1536) | 3MP (2048 × 1536) | - |
| Pixel Pitch | Horizontal: 0.2115 mm
Vertical: 0.2115 mm | Horizontal: 0.2115 mm
Vertical: 0.2115 mm | - |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 38.7% | 57.1% | The diagnostic performance is equivalent
to that of the predicate devices, though the
aperture ratio is higher. |
| Subpixel driving (spatial
and temporal dithering) | N/A | N/A | - |
| Display Interface | Input:
DVI-D x1
DisplayPort x1
Output:
DisplayPort x1 | Input:
DisplayPort x2
USB-C x1
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: 216 MHz | Dot clock: 216 MHz | - |
| | Predicate device
LCD Monitor CL-S300 | Proposed device
LCD Monitor CL-S301 | Explanation of
Differences |
| User controls | DICOM CONFORMANCE TEST
CONFIGURATION
INPUT SOURCE
DYNAMIC GAMMA
AUTO TEXT MODE
FUNCTON
EDID
TEST PATTERN
FACTORY PRESET
USB POWER
INPUT SOURCE AUTO SCANNING
HUMAN SENSOR
DISPLAYPORT | DICOM CONFORMANCE TEST
CONFIGURATION
INPUT SOURCE
DYNAMIC GAMMA
AUTO TEXT MODE
FUNCTION
EDID
TEST PATTERN
FACTORY PRESET
USB POWER
MULTI PIXEL ENHANCER
TURBO LUMINANCE
COLOR MODE
USB UP-PORT INPUT SELECT
USB-C DATA SETTING
SELF CALIBRATION RESULT
DISPLYPORT VERSION
RECOMMENDED REPLACE TIMING
VISUAL POINT MODE | The performance of the proposed device is
the same as the predicate device, though
some user controls were added or
removed. |
| 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 | – |
| Additional
Software/Firmware | N/A | N/A | – |
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7
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) | Lmin and Lmax 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) | |
| I. 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.