COLOR LCD MONITOR, RADIFORCE, MODEL RX210

K063120 · Eizo Nanao Corporation · LLZ · Nov 9, 2006 · Radiology

Device Facts

• Record ID: K063120
• Device Name: COLOR LCD MONITOR, RADIFORCE, MODEL RX210
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

RadiForce RX210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

Device Story

RadiForce RX210 is a 21.3-inch color LCD medical display; used by trained medical practitioners in clinical settings for viewing high-definition diagnostic images (X-ray, MRI). Device receives digital image input via DVI interface; transforms input for high-resolution visualization; features Digital Uniformity Equalizer (DUE) to compensate for luminance non-uniformity. Output is a high-brightness (600 cd/m²) visual display; assists clinicians in diagnostic decision-making. Benefits include improved image clarity and luminance consistency compared to previous models.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

54cm (21.3") TFT color LCD panel; 1600 x 1200 resolution; 600 cd/m² brightness; 600:1 contrast ratio; 25ms response time. Connectivity via DVI-D and D-sub mini 15 pin; USB 2.0 ports. Features Digital Uniformity Equalizer (DUE) for luminance compensation. Compliant with EN60601-1, UL60601-1, CSA C22.2 No. 601-1, FCC-B, and CE Medical Device Directive.

Indications for Use

Indicated for trained medical practitioners to display and view digital images for diagnosis of X-ray or MRI. Not indicated for digital mammography systems.

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

• RadiForce R22 (K033466)

Submission Summary (Full Text)

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K063120

NOV - 9 2006

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. ...

# 510(k) Summary as required by 807.92

## 1. Company Identification EIZO NANAO CORPORATION 153 Shimokashiwano cho, Hakusan shi, Ishikawa ken, 924-8566, Japan Tel: [phone] Fax: [phone]

- 2. Official Correspondent
Hiroaki Hashimoto (Mr.) Manager of Engineering Management Section

- 3. Date of Submission October 2nd, 2006
- 4. Device Trade name Color LCD Monitor, RadiForce RX210
- 5. Common/Usual Name Image display system, medical image workstation, image monitor/display, and others
- 6. Classification Number

Medical displays classified in Class II ver 21 CFR 892,2050.

- 7. Predicate Device
Manufacturer : EIZO NANAO CORPORATION Device Name .. Color LCD Monitor Model Name : RadiForce R22 510(k) No. : K033466

#### 8. Description of Device

RadiForce RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 displays high-definition medical imaging.

#### 9. Intended Use

RadiForce RX210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

### 10. Technological Characteristics

RadiForce RX210 is substantially equivalent to R22. RX210 employs the maximum resolution values same as that of R22. Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non uniformity, And the brightness improved.

Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.

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| Items | R22 | RX210 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K033466 | Not known |
| Panel Size and Type | 54 cm (21.3") TFT color LCD panel | It is same as the following. |
| Cabinet Color | Black | It is same as the following. |
| Pixel Pitch | 0.270 x 0.270mm | It is same as the following. |
| Display colors | 1.6777,216 colors | It is same as the following. |
| Viewing Angles | H: 170°, V: 170° | It is same as the following. |
| Scanning Frequency<br>(H, V) | Analog:31-94kHz, 49-86Hz<br>Digital:31-76, 59-61Hz<br>(VGA Text:69-71Hz) | Analog:24-100kHz, 49-86Hz<br>Digital:31-100kHz, 59-61Hz<br>(VGA Text:69-71Hz) |
| Native Resolutions | 1600 x 1200 (landscape) | It is same as the following. |
| Brightness | 250 cd/m² | 600 cd/m² (Typical) |
| Contrast Ratio | 400: 1 (typical) | 600: 1 (typical) |
| DOT Clock | Analog:202.5MHz<br>Digital:162MHz | Analog:202.5MHz<br>Digital: 162MHz |
| Response Time | 50 ms (typical) | 25 ms (typical) |
| Active Display Size<br>(H x V) | 432mm x324mm | It is same as the following. |
| Viewable Image Size | 540 mm (21.3") (diagonal) | It is same as the following. |
| Luminance Calibration | Software (Optional)<br>Photo-sensor (Optional)<br>Protection Panel (Optional) | Software (Optional)<br>Photo-sensor (Optional)<br>Protection Panel (Optional)<br>Digital Uniformity Equalizer |
| Input Signals | RGB Analogue<br>DVI Standard 1.0 | It is same as the following. |
| Input Terminals | DVI-D 29 pin<br>D-sub mini 15 pin | It is same as the following. |
| USB Ports / Standard | 1 upstream / Rev.1.1 | 1 upstream, 2<br>downstream/Standard Rev.2.0 |
| Power | AC100-120V, 200-240V, 50/60Hz | It is same as the following. |
| Power Management | DVI-DMPM<br>VESA DPMS | It is same as the following. |
| Dimensions (W x H x D) | With Stand:<br>472 x 459 mm- 541 x 208.5 mm<br>Without Stand:<br>472 x 373 x 69 mm | With Stand:<br>376 x 522.5 mm- 604.5x 208.5 mm<br>Without Stand:<br>376 x 500 x 92 mm |
| Certifications &<br>Standards | TUV/GM, CE Medical Device<br>Directive, CB (EN60601-1),<br>cTUVus (UL2601-1, CSA C22.2 No.<br>601-1), VCCI-B, FCC-B, Canadian<br>ICES-003-B, CCC | TUV/GM, CE Medical Device<br>Directive, CB (EN60601-1),<br>cTUVus (UL60601-1, CSA C22.2<br>No. 601-1), VCCI-B, FCC-B,<br>Canadian ICES-003-B, CCC |

# Appendix 1: Comparison Table with Predicate Device

Since the software used in R22 is not changed, refer to the 510(k) Summary of 5033466 for the information of calibration software.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized depiction of three human faces in profile, stacked on top of each other. The faces are drawn with thick, black lines, giving them a bold and graphic appearance. To the left of the faces, there is text arranged in a curved, vertical format, although the specific words are not clear due to the image quality.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Hiroaki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 JAPAN

NOV - 9 2006

Re: K063120

Trade/Device Name: Color LCD Monitor, Radiforce RX210 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 2, 2006 Received: October 12, 2006

## Dear Mr. Hashimoto:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three dots at the bottom of the circle.

ing Public .

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-0500

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities.under the Act from the Division of Small Manufacturers, International and Consumer Assommer Assommer at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2 -

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Indications for Use

510(k) Number (if known): Not known KOG 3120

Color LCD Monitor, RadiForce RX210 Device Name :

Indications For Use:

RadiForce RX210 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. TThe device is not specified for digital mammography system.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

Division of Reproductive. Abdomin and Radiological Devices 510(k) Number