2MP Color LCD Monitor CL-R211

K182539 · Jvckenwood Corporation · PGY · Oct 3, 2018 · Radiology

Device Facts

• Record ID: K182539
• Device Name: 2MP Color LCD Monitor CL-R211
• Applicant: Jvckenwood Corporation
• Product Code: PGY · Radiology
• Decision Date: Oct 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

CL-R211 is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.

Device Story

2MP Color LCD Monitor (CL-R211) displays medical images for diagnostic review by trained practitioners. Device accepts digital video input via DVI or DisplayPort interfaces. Features include TFT IPS panel with LED backlighting, built-in front sensor, ambient light sensor, and human presence sensor for automated display management. Used in clinical environments; output viewed by physicians/technicians to support diagnostic decision-making. Uniformity correction system ensures image consistency. Device provides high-resolution visualization of medical imaging data.

Clinical Evidence

Bench testing only. Performance verified against AAPM-TG18 guidelines for luminance response, angular dependency, luminance uniformity, and chromaticity. Pixel defects evaluated per ISO13406-2. No clinical data provided.

Technological Characteristics

TFT Color LCD Panel (IPS) with LED backlighting. Resolution 1600x1200 (landscape) / 1200x1600 (portrait). Connectivity: DVI-D, DisplayPort, USB 2.0. Integrated sensors: front sensor, ambient light sensor, human presence sensor. Uniformity correction system. Power: AC100-240V. Compliance: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC Class B, VCCI-B. Standards: AAPM-TG18 (luminance, reflection, chromaticity), ISO13406-2 (pixel defects).

Indications for Use

Indicated for trained medical practitioners or certified personnel to display 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) Color LCD Monitor CCL214 (CL21214/ K161895)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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. The logos are simple and professional in appearance.

JVC Kenwood Corporation c/o Masafumi Yugami Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama, Kanagawa 221-0022 JAPAN

October 3, 2018

Re: K182539

Trade/Device Name: 2MP Color LCD Monitor CL-R211 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: September 12, 2018 Received: September 14, 2018

Dear Masafumi Yugami:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D. O'Hara

for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K182539

Device Name 2MP Color LCD Monitor CL-R211

Indications for Use (Describe)

CL-R211 (CL-R211xxxxx) is intended to be used in displaying medical images for diagnosis by trained medical practitioners or certified personnel.

It is not meant to be used in digital mammography.

| Type of Use ( <i>Select one or both, as applicable</i> ) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <table border="0"><tr><td><span style="font-size: 10pt"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span></td><td><span style="font-size: 10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span></td></tr></table> | <span style="font-size: 10pt"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
| <span style="font-size: 10pt"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size: 10pt"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | |

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## JVCKENWOOD

## 510(k) SUMMARY

| Submitted Information: | JVC KENWOOD Corporation<br>3-12, Moriya-cho, Kanagawa-ku,<br>Yokohama-shi, Kanagawa, 221-0022 Japan | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Masafumi Yugami, Manager<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] | |
| Date Prepared: | September 12, 2018 | |
| Device Name: | 2MP Color LCD Monitor<br>CL-R211 | |
| Common Name: | CL-R211<br>(CL-R211xxxxx) | |
| Classification Name: | Class II<br>(Part 892 Radiology Devices<br>Sec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 21.3 inch (54cm) Color LCD Monitor CCL214<br>(CL21214/ K161895) | |
| Device Description: | <Resolution><br>CL-R211 : 1600 x 1200 (landscape), 1200 x 1600 (portrait)<br><br>DVI (digital interface) and DisplayPort (digital interface) | |
| Intended Use: | CL-R211 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: | CL-R211 shares the same technical characteristics, application, and<br>intended use as our predicate device CCL214 (CL21214 / K161895) | |

JVC KENWOOD Corporation

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| Technical Specification |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Luminance Response<br>[SPEC] Less than $\pm$ 10% based on AAPM-TG18 4.3. |
| 2. Angular Dependencies<br>[SPEC] More than angle of 20° LR' $\delta$ , $\theta$ ≥ 175, k $\delta$ , $\theta$ ≤ 30% based on AAPM-TG18 4.4. |
| 3. Luminance Uniformity<br>[SPEC] Less than 30% based on AAPM-TG18 4.4.4 |
| 4. Pixel Defects / Fault<br>[SPEC] Class II or more. ISO13406-2 |
| 5. Artifacts<br>- phase/clock issues flicker<br>- miscellaneous including ringing, ghosting, image sticking<br>[SPEC] By visible check, no flicker, ringing, ghosting and image sticking. |
| 6. Chromaticity Measurement of 5%, 50%, 95% Level |
| 7. Chromaticity<br>[SPEC] $\triangle$ (u' , v' ) ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 8. Power On Luminance Drift<br>[SPEC] $\triangle$ Lmax≤ $\pm$ 10% within 60 seconds.<br>$\triangle$ Lmax : the deviation between the target maximum luminance and the measured luminance. |
| 9. Reflection<br>Based on AAPM-TG18 4.2. |

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## Substantial Equivalence Comparison

| | CCL214 (CL21214) | CL-R211(CL-R211xxxxx) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K161895 | Not Known |
| Resolution or Matrix Size | 2MP(1200 x 1600) | 2MP(1200 x 1600) |
| Screen Technology | TFT Color LCD Panel (IPS) | TFT Color LCD Panel (IPS) |
| Backlighting | LED | LED |
| Maximum Luminance | 500 cd/m2 typ. | 500 cd/m2 typ. |
| DICOM | | |
| Calibrated Luminance | 250 cd/m² | 250 cd/m² |
| Viewing Angle | CR>10:1<br>Horizontal: Typ.178 Vertical: Typ.178 | CR>10:1<br>Horizontal: Typ.178 Vertical: Typ.178 |
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm | Horizontal: 432.0mm, Vertical: 324.0mm |
| Response Time (typical) | 10% – 90%<br>Ton 8ms Typ. Toff 8ms Typ. | 10% – 90%<br>Ton 8ms Typ. Toff 8ms Typ. |
| Aspect Ratio | 3:4 | 3:4 |
| Pixel Pitch | Horizontal: 0.270mm, Vertical: 0.270mm | Horizontal: 0.270mm, Vertical: 0.270mm |
| Contrast Ratio | 1200:1 | 1800:1 |
| Grayscale Tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones<br>8-bit: 256 from a palette of65,473 tones | 10-bit (DisplayPort): 1,024from a palette of 65,473 tones<br>8-bit: 256 from a palette of65,473 tones |
| Non-Uniformity | | |
| Compensation | Uniformity correction System | Uniformity correction System |
| Input Video Signal | DVI-D 24-pin connector, DisplayPort connector | DVI-D 24-pin connector, DisplayPort connector |
| USB Ports / Standard | USB: upstream port (x 1), downstream port (x 2)<br>Ver 2.0 | USB: upstream port (x 1), downstream port (x 2)<br>Ver 2.0 |
| | CCL214 (CL21214) | CL-R211(CL-R211xxxxx) |
| Scanning Frequency | DVI<br>Horizontal:74.1KHz, Vertical: 60Hz (Landscape)<br>Horizontal:98.1KHz, Vertical: 60Hz (Portrait)<br>DisplayPort<br>Horizontal:75.0KHz, Vertical: 60Hz (Landscape)<br>Horizontal:99.0KHz, Vertical: 60Hz (Portrait) | DVI<br>Horizontal:74.1KHz, Vertical: 60Hz (Landscape)<br>Horizontal:98.1KHz, Vertical: 60Hz (Portrait)<br>DisplayPort<br>Horizontal:75.0KHz, Vertical: 60Hz (Landscape)<br>Horizontal:99.0KHz, Vertical: 60Hz (Portrait) |
| Maximum Image Clock | 162MHz | 162MHz |
| Rated | AC100-240V, 50/60Hz<br>1.4 - 0.7A | AC100-240V, 50/60Hz<br>2.2 - 1.1A |
| Luminance Calibration<br>(Optional) | Software<br>Photo Sensor (optional): X-Rite i1Display | Software<br>Photo Sensor (optional): X-Rite i1Display |
| Sensor | Built-in Front Sensor<br>Built-in Ambient Light Sensor<br>None | Built-in Front Sensor<br>Built-in Ambient Light Sensor<br>Built-in Human presence sensor |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1,<br>FCC (Class B), ICES-003 (Class B),<br>MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1,<br>FCC (Class B), ICES-003 (Class B),<br>MDD/CE, VCCI-B (Class B) |
| Weight & Dimension | Net: 11.1kg<br>367.0(w) x 521.9 – 583.4(H) x 220(D) mm<br>Packed: Approx.14.0kg<br>470(w) x 670(H) x 340.0(D) mm | Net: 8.9kg<br>361.5(w) x 517 – 612(H) x 196.5(D) mm<br>Packed: Approx.11.9kg<br>585(w) x 580(H) x 285(D) mm |

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