Who is the manufacturer of 12MP Color Digital Mammography LCD Monitor CL-S1200?

Jvckenwood Corporation filed the 510(k) submission for 12MP Color Digital Mammography LCD Monitor CL-S1200 (K203733).

What is the FDA product code for 12MP Color Digital Mammography LCD Monitor CL-S1200?

PGY. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for 12MP Color Digital Mammography LCD Monitor CL-S1200?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 12MP Color Digital Mammography LCD Monitor CL-S1200?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

12MP Color Digital Mammography LCD Monitor CL-S1200

K203733 · Jvckenwood Corporation · PGY · Jun 29, 2021 · Radiology

Device Facts

Record ID	K203733
Device Name	12MP Color Digital Mammography LCD Monitor CL-S1200
Applicant	Jvckenwood Corporation
Product Code	PGY · Radiology
Decision Date	Jun 29, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2

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.

Device Story

The CL-S1200 is a 30.9-inch color LCD monitor designed for high-resolution medical image display, including mammography. It receives digital video input via DisplayPort and renders images on an IPS LCD panel with a 4200 x 2800 resolution. The device features an integrated luminance sensor and control circuit to maintain stable luminance and grayscale characteristics (DICOM GSDF). It includes luminance and color mura correction functions to ensure screen uniformity and a protective glass filter. Used in clinical environments, the monitor is operated by radiologists or medical practitioners to view diagnostic images. The output provides high-fidelity visualization of medical imaging data, supporting clinical decision-making by ensuring accurate, standardized image presentation. The device benefits patients by facilitating precise diagnostic review of mammographic and tomosynthesis images.

Clinical Evidence

Bench testing only. Performance was verified against AAPM-TG18 and IDMS 1.03 standards. Tests included spatial resolution (MTF), pixel defects (ISO 13406-2), temporal response, luminance stability, grayscale-to-luminance conformance (DICOM GSDF), luminance uniformity/Mura, spatial noise, reflection coefficients, veiling glare, and color/gray tracking. Results demonstrate the device meets all specified performance criteria for diagnostic medical displays.

Technological Characteristics

30.9-inch IPS LCD panel, TFT active-matrix, LED backlight. Resolution: 4200 x 2800 (12MP). Pixel pitch: 0.1554mm. Connectivity: 2x DisplayPort input, 1x DisplayPort output. Integrated luminance sensor for calibration. Software: QA Medivisor Agent. Standards: AAPM-TG18, ISO 13406-2, IDMS 1.03, IEC 62563-1.

Indications for Use

Indicated for trained medical practitioners or certified personnel to display and view medical images for diagnosis, including digital mammography PACS, digital breast tomosynthesis, and FFDM.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

CL-S500 (K191137)

Related Devices

K210491 — CW120N · Wide Corporation · Apr 8, 2021
K231026 — 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) · Shenzhen Beacon Display Technology Co., Ltd. · Aug 18, 2023
K191137 — 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 · Jvckenwood Corporation · Jul 2, 2019
K151007 — 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) · Jvckenwood Corporation · May 8, 2015
K241105 — 3MP Color LCD Monitor (CL-S301) · Jvckenwood Corporation · Aug 1, 2024

Submission Summary (Full Text)

{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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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}------------------------------------------------ ## 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.