(190 days)
Not Found
No
The description focuses on the physical characteristics and display technology of a medical monitor, with no mention of AI or ML algorithms for image analysis or processing.
No
This device is a monitor intended for displaying and viewing medical images for diagnosis, not for treating or preventing a disease or condition.
No
Explanation: The device is a medical monitor designed for displaying medical images for diagnosis, but it does not perform the diagnosis itself. Its function is to present images, not to generate diagnostic outputs or analyses.
No
The device description clearly describes a physical hardware product (LCD Monitor) with specific hardware components and functions (LCD panel, luminance sensor, luminance control circuit, glass filter). While it displays medical images, it is not solely software.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CL-S1200 is a medical image display monitor. Its purpose is to display medical images (specifically mammography images) for viewing and diagnosis by trained medical practitioners. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying and viewing medical images for diagnosis." This aligns with the function of a medical display, not an IVD.
- Device Description: The description focuses on the technical specifications of the monitor (LCD panel, luminance, calibration, etc.) and how it displays images accurately. There is no mention of analyzing biological samples or performing diagnostic tests on them.
- Input Modality: The input is medical imaging data (digital mammography, breast tomosynthesis, FFDM), not biological samples.
In summary, the CL-S1200 is a medical device used in the process of diagnosis, but it is a display device and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
30.9 inch Color Digital Mammography LCD Monitor
4200 x 2800 (landscape)
■ High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display including mammography.
■ 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.
■ A glass filter protects the surface of the LCD panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital mammography PACS, digital breast tomosynthesis and modalities including FFDM
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:
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.
g. Luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners (For mammography displays): AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies
h. Luminance uniformity or Mura test (For mammography displays): AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies
i. Stability of luminance and chromaticity response with temperature and time of operation or on-time (For mammography displays): Temperature: Luminance and chromaticity response in 0 °C, 20 °C, 25 °C, 30 °C, and 40 °C. Time: Luminance and chromaticity are measured after the AC power of the display is turned on.
j. Spatial noise (For mammography displays): The uniform area including the two lines is displayed and captured by a digital camera equipped with a macro lens. The noise power spectrum is calculated with the captured data.
k. Reflection coefficient (For mammography displays): AAPM-TG18, 4.2 Display Reflection. Specular and Diffuse reflection coefficients are measured.
l. Veiling glare or small-spot contrast (For mammography displays): AAPM-TG18, 4.7 Veiling Glare
m. Color tracking (primary colors and color gamut) (For color displays): 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) (For color displays): AAPM-TG196 Gray Tracking, IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation
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.
CL-S500/ K191137
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
June 29, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
Re: K203733
Trade/Device Name: 12MP Color Digital Mammography LCD Monitor CL-S1200 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 21, 2021 Received: May 26, 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 (reporting of medical device-related adverse events) (21 CFR 803) for devices
1
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
2
Indications for Use
510(k) Number (if known) K203733
Device Name
12MP Color Digital Mammography LCD Monitor CL-S1200
Indications for Use (Describe)
CL-S1200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
JVCKENWOOD
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: | May 21, 2021 | | |
| Device Name: | 12MP Color Digital Mammography LCD Monitor CL-S1200 | | |
| Common Name: | display, diagnostic radiology | | |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Medical Image Management and Processing System) | | |
| Predicate Device: | 21.3 inch (54cm) Color LCD Monitor CL-S500
(CL-S500/ K191137) | | |
| Device Description: | 30.9 inch Color Digital Mammography LCD Monitor
4200 x 2800 (landscape)
■ High-luminance color LCD panel, which has wide view angle, is
used for this product. It is designed for medical image display
including mammography.
■ 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.
■ A glass filter protects the surface of the LCD panel. | | |
JVCKENWOOD Corporation
4
JVCKENWOOD
| Cybersecurity: | FDA guidance located at
https://www.fda.gov/media/86174/download, are followed for
cybersecurity concerns. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | CL-S1200 is intended to be used in displaying and viewing medical
images for diagnosis by trained medical practitioners or certified
personnel.
It's intended to be used in digital mammography PACS, digital breast
tomosynthesis and modalities including FFDM. |
| stantial Equivalence: | CL-S1200 shares the same technical characteristics application |
- Substantial Equivalence: CL-S1200 shares the same technical characteristics, application, and intended use as our predicate device CL-S500/ K191137.
JVCKENWOOD Corporation
Healthcare Business Division 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan
5
Device Description & Substantial Equivalence Comparison
| | Predicate device | Proposed device | Explanation of
Differences |
|----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | LCD Monitor CL-S500
K191137 | LCD Monitor CL-S1200 | — |
| Indication for use | CL-S500 is intended to be used in
displaying and viewing medical images for
diagnosis by trained medical practitioners
or certified personnel.
They're intended to be used in digital
mammography PACS, digital breast
tomosynthesis and modalities including
FFDM. | CL-S1200 is intended to be used in
displaying and viewing medical images for
diagnosis by trained medical practitioners
or certified personnel.
It's intended to be used in digital
mammography PACS, digital breast
tomosynthesis and modalities including
FFDM. | — |
| 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" (54.1cm)
Aspect ratio: 4:5 | Diagonal: 30.9" (78.4cm)
Aspect ratio: 3:2 | Half of the screen size of the proposed
device is the same as the predicate
device. |
| Backlight type | LED | LED | — |
| Frame rate and refresh
rate | Portrait:
Horizontal: 129.1KHz
Vertical: 50Hz
Landscape:
Horizontal: 103.5KHz
Vertical: 50Hz | Landscape:
Horizontal: 170.5 kHz
Vertical: 60 Hz | Although refresh rate of the proposed
device is higher than the predicate device,
the difference is not distinguishable when
observing still images. |
| Resolution / Pixel array | 5MP (2048 x 2560) | 12MP (4200 x 2800) | Less than half of the resolution of the
proposed device is the same as the
predicate device. |
| Pixel Pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.1554mm
Vertical: 0.1554mm | Pixel pitch of the proposed device is equal
to smaller than that of the predicated
device. |
| Subpixel pattern | Stripe RGB | Stripe RGB | — |
| Pixel aperture ratio | 53.00% | 56.50% | Almost the same. |
| Subpixel driving (spatial
and temporal dithering) | N/A | N/A | — |
| Display Interface | Input:
DVI-D x1
DisplayPort x1
Output:
DisplayPort x1 | 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: 285 MHz | Dot clock: 746 MHz | Since the resolution and refresh rate are
higher than the predicate device, the dot
clock of the proposed device is higher. |
| User controls | Input signal switch
Dynamic gamma
AUTO TEXT
Configuration switch,
DisplayPort Power,
USB Power | Input signal switch
Dynamic gamma
AUTO TEXT
EDID switch
Configuration switch
DisplayPort Power
USB Power
Pixel Enhancer
Turbo Luminance
Dynamic Range Extension
Auto Config Select | The functions in the predicate device are
also available in the proposed device. |
| 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 | – |
6
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 | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies |
| (For mammography displays) | |
| h. Luminance uniformity or Mura test | AAPM-TG18, 4.4 Luminance Spatial and Angular Dependencies |
| (For mammography displays) | |
| i. Stability of luminance and chromaticity | |
| response with temperature and time of | |
| operation or on-time | Temperature: |
| Luminance and chromaticity response in 0 °C, 20 °C, 25 °C, | |
| 30 °C, and 40 °C | |
| Time: | |
| Luminance and chromaticity are measured after the AC power | |
| of the display is turned on. | |
| (For mammography displays) | |
| j. Spatial noise | The uniform area including the two lines is displayed and |
| captured by a digital camera equipped with a macro lens. The | |
| noise power spectrum is calculated with the captured data. | |
| (For mammography displays) | |
| k. Reflection coefficient | AAPM-TG18, 4.2 Display Reflection |
| Specular and Diffuse reflection coefficients are measured. | |
| (For mammography displays) | |
| I. Veiling glare or small-spot contrast | AAPM-TG18, 4.7 Veiling Glare |
| (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.