2MP Monochrome LCD Monitor MS-S200

K210345 · Jvckenwood Corporation · PGY · Apr 23, 2021 · Radiology

Device Facts

• Record ID: K210345
• Device Name: 2MP Monochrome LCD Monitor MS-S200
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

MS-S200 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.

Device Story

2MP monochrome LCD monitor for medical image display; inputs video signals via DVI-D or DisplayPort; transforms signals into grayscale images compliant with DICOM GSDF; features built-in luminance sensor and control circuit for stability; uniformity correction function minimizes luminance unevenness; includes ambient light sensor and human presence sensor for energy management; used by radiologists or clinicians in clinical settings; output allows visual diagnosis of medical images; benefits patient through accurate, stable, and uniform image visualization.

Clinical Evidence

Bench testing only. Performance specifications verified against AAPM-TG18 and ISO 13406-2 standards. Physical evaluation confirmed superior response time and contrast ratio compared to predicate.

Technological Characteristics

21.3-inch TFT Monochrome IPS LCD panel; 1600x1200 resolution; LED backlighting; luminance stabilization via built-in sensor; uniformity correction; connectivity via DVI-D and DisplayPort; USB 2.0 ports; power 100-240V AC; standards: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC Class B, ICES-003 Class B, MDR/CE, RCM, VCCI-B.

Indications for Use

Indicated for trained medical practitioners or certified personnel to display and view medical images for diagnostic purposes. Not for use in digital mammography.

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

• 21.3 inch (54cm) Monochrome LCD Monitor MS25i2 (ML21025) (K133511)

Submission Summary (Full Text)

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April 23, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes 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

#### Re: K210345

Trade/Device Name: 2MP Monochrome LCD Monitor MS-S200 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 29, 2021 Received: February 5, 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

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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 ([e-mail]) or phone [phone] 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) K210345

Device Name 2MP Monochrome LCD Monitor MS-S200

Indications for Use (Describe)

MS-S200 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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#### JVCKENWOO DID

# 510(k) SUMMARY

| Submitted Information: | JVCKENWOOD Corporation<br>3-12, Moriya-cho, Kanagawa-ku,<br>Yokohama-shi, Kanagawa, 221-0022 Japan |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hideki Tengeiji, Senior Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | April 13, 2021 |
| Device Name: | 2MP Monochrome LCD Monitor MS-S200 |
| Common Name: | MS-S200<br>(MS-S200xxxxx) |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54cm) Monochrome LCD Monitor MS25i2 (ML21025)<br>(MS25i2/ K133511) |
| Device Description: | 21.3 inch (54cm) Monochrome LCD Monitor<br>1600 x1200 (landscape) |
| | High-luminance monochrome LCD panel, which has wide view<br>angle, is used for this product. It is designed for medical image<br>display.<br>Luminance stabilization function composed with luminance<br>sensor and luminance control circuit always observes the<br>luminance and makes it stable.<br>Images are faithfully displayed along grayscale characteristics<br>(DICOM GSDF) based on the calibrated data stored to the lookup<br>table of the monitor.<br>It minimizes luminance unevenness by Uniformity Correction<br>Function to achieve the uniformity of luminance on the whole<br>screen.<br>Quantitative evaluation and visual evaluation are done before<br>the shipment. Quality control along the QC guideline is conducted. |
| Intended Use: | MS-S200 is intended to be used in displaying and viewing medical<br>images for diagnosis by trained medical practitioners or certified<br>personnel.<br>It is not meant to be used in digital mammography. |
| Substantial Equivalence: | MS-S200 shares the same technical characteristics, application, and<br>intended use as our predicate device MS25i2/K133511. |
| Validation for Performance<br>Specification: | All items in monitor specification have met the acceptance criteria<br>according to the standard, AAPM-TG18 and ISO 13406-2. |
| Changes in the new<br>monitor, MS-S200: | 1) Response Time<br>19 ms (new monitor:MS-S200) vs. 40 ms (predicate device:MS25i2)<br>The specification of the proposed device (MS-S200) is superior to that of<br>the predicate device (MS25i2).<br>2) Contrast Ratio<br>1800:1 (new monitor:MS-S200) vs. 1400:1 (predicate device:MS25i2)<br>The specification of the proposed monitor (MS-S200) is superior to that<br>of the predicate device (MS25i2) |
| Conclusion: | Based on our specification confirmation and physical evaluation as<br>above, the proposed device is substantial equivalent to the predicate |

K210345

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## JVCKENWOOD

device.

## JVCKENWOOD Corporation
Healthcare Business Division

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### Substantial Equivalence Comparison

| | Predicate Device<br>MS25i2 (ML21025) | Proposed Device<br>MS-S200 (MS-S200xxxxx) | Explanation of<br>Differences | Response Time (typical) | T on + T off (10%-90%)<br>40 ms typ. | T on + T off (10%-90%)<br>19 ms typ. | The specification of the<br>proposed device is<br>superior to that of the<br>predicate device. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 510(k) Number | K133511 | Not Known | — | Aspect Ratio | 3:4 | 3:4 | – |
| Indication for Use | 21.3 inch (54 cm) Monochrome 2M pixel LCD<br>Monitor MS25i2 (ML21025) is intended to be<br>used in displaying and viewing medical images<br>for diagnosis by trained medical practitioners or<br>certified personnel.<br>It is not meant to be used in digital<br>mammography. | 21.3 inch (54 cm) Monochrome 2M pixel LCD<br>Monitor MS-S200 (MS-S200xxxxx) is<br>intended to be used in displaying and viewing<br>medical images for diagnosis by trained<br>medical practitioners or certified personnel.<br>It is not meant to be used in digital<br>mammography. | — | Pixel Pitch | Horizontal: 0.270 mm, Vertical: 0.270 mm | Horizontal: 0.270 mm, Vertical: 0.270 mm | – |
| Resolution or Matrix Size | Portrait : 1200 x 1600 (4800 subpixel)<br>Landscape : 1600 (4800 subpixel) x 1200 | Portrait : 1200 x 1600 (4800 subpixel)<br>Landscape : 1600 (4800 subpixel) x 1200 | — | Contrast Ratio | 1400:1 | 1800:1 | The specification of the<br>proposed device is<br>superior to that of the<br>predicate device. |
| Screen Technology | TFT Monochrome LCD Panel (IPS) | TFT Monochrome LCD Panel (IPS) | — | Grayscale Tones | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | – |
| Backlighting | LED | LED | — | Non-Uniformity<br>Compensation | N/A | N/A | – |
| Maximum Luminance | 1900 cd/m² typ. | 1900 cd/m² typ. | — | Input Video Signal | DVI-D, DisplayPort | DVI-D, DisplayPort | – |
| DICOM<br>Calibrated Luminance | 0.8 - 410 cd/m² | 0.8 - 410 cd/m² | — | USB Ports / Standard | USB:<br>Upstream port (x1), Downstream port (x2)<br>Ver.2.0 | USB:<br>Upstream port (x1), Downstream port (x2)<br>Ver.2.0 | – |
| Viewing Angle | CR>10:1<br>Viewing angle :<br>Horizontal: Typ.176 Vertical: Typ.176 | CR>10:1<br>Viewing angle :<br>Horizontal: Typ.178 Vertical: Typ.178 | The specification of the<br>proposed device is<br>superior to that of the<br>predicate device. | Scanning Frequency | DVI<br>74.1KHz, Vertical: 60Hz (Landscape)<br>98.1KHz, Vertical: 60Hz (Portrait)<br>DisplayPort<br>75.0KHz, Vertical: 60Hz (Landscape)<br>99.0KHz, Vertical: 60Hz (Portrait) | DVI<br>74.1KHz, Vertical: 60Hz (Landscape)<br>98.1KHz, Vertical: 60Hz (Portrait)<br>DisplayPort<br>75.0KHz, Vertical: 60Hz (Landscape)<br>99.0KHz, Vertical: 60Hz (Portrait) | – |
| Display Area | Horizontal: 324.0 mm, Vertical: 432.0 mm | Horizontal: 324.0 mm, Vertical: 432.0 mm | — | Maximum Image Clock | 162MHz | 162MHz | – |
| Rated | AC100-240V, 50/60Hz 1.5 – 0.6A | AC100-240V, 50/60Hz 2.2 – 1.1A | The difference does not<br>affect diagnosis. | | | | |

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| Luminance Calibration<br>(Optional) | Software: Medivisor Nx<br>Calibration Sensor (Optional): Chroma5 (X-Rite) | Software: F-CAL, Medivisor Agent<br>Calibration Sensor (Optional): i1Display (X-Rite) | Application software and<br>calibration sensor of the<br>proposed device currently<br>support those of the<br>predicate device. |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Sensor | Built-in Front Sensor | Built-in Front Sensor | Adding human presence<br>sensor does not affect<br>diagnosis, only for energy |
| | Built-in Ambient Light Sensor | Built-in Ambient Light Sensor | saving. |
| | None | Built-in Human presence sensor | |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.<br>60601-1, FCC (Class B), ICES-003 (Class B),<br>MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.<br>60601-1, FCC (Class B), ICES-003 (Class B),<br>MDR/CE, RCM, VCCI-B (Class B) | Safety standards of the<br>predicate device currently<br>support those of the<br>proposed device.<br>(RCM is added) |
| Weight & Dimension | Net: Approximately 12.0kg<br>Landscape:<br>474.0 (w) x 468.4 - 529.9 (H) x 220.0 (D) mm<br>Portrait:<br>367.0 (w) x 521.9 - 583.4 (H) x 220.0 (D) mm<br>Packed: Approximately 15.0kg<br>470 (W) x 670 (H) x 340 (D) mm | Net: Approximately 9.3 kg (Filter Model)<br>Approximately 8.9 kg (Normal Model)<br>Landscape:<br>493.0 (w) x 451.3 – 546.3 (H) x 196.5 (D) mm<br>Portrait:<br>361.5 (w) x 517.0 - 612.0 (H) x 196.5 (D) mm<br>Packed: Approximately 12.3kg (Filter Model)<br>Approximately 11.9kg (Normal Model)<br>585 (W) x 580 (H) x 285 (D) mm | The difference does not<br>affect diagnosis. |