20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

K030347 · Eizo Nanao Corporation · LLZ · May 2, 2003 · Radiology

Device Facts

• Record ID: K030347
• Device Name: 20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.

Device Story

RadiForce G20 is a 20.1-inch monochrome TFT LCD monitor for medical imaging. It receives digital video input via DVI-D interface from medical imaging systems (X-ray, MRI). The device displays grayscale images at resolutions of 1600x1200 or 1200x1600. It is intended for use by clinicians in a medical environment to view diagnostic images. The monitor features a 1000:1 contrast ratio and 700 cd/m² brightness to support diagnostic interpretation. It includes power management (DVI-DMPM) and peripheral connectivity via USB and serial ports for remote control and sensor integration. The device aids healthcare providers in visualizing diagnostic data to support clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

20.1" TFT monochrome LCD panel; 1600x1200/1200x1600 resolution; 700 cd/m² brightness; 1000:1 contrast ratio; DVI-D input; USB 1.1 and serial ports; power management (DVI-DMPM); certified to IEC60601-1, UL2601-1, CSA C22.2 No. 601-1.

Indications for Use

Indicated for use in displaying medical images for the diagnosis of X-ray or MRI studies.

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

• 20.8" Monochrome LCD Monitor, FC-2091 (K022109)

Submission Summary (Full Text)

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#### 510(k) Summary as required by 807.92

# 1. Company Identification

K030347

EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Matto-shi, Ishikawa-ken, 924-8566, Japan Tel: [phone] Fax: [phone]

## 2. Official Correspondent

Hiroaki Hashimoto (Mr.)

### 3. Date of Submission

January 27, 2003

### 4. Device Trade name

20.1" Monochrome LCD Monitor, RadiForce G20

#### 5. Common Name

Monitor, display, workstation, and others

### 6. Classification

Medical displays were classified in Class II per 21 CFR 890.2050.

### 7. Predicate Device

20.8" Monochrome LCD Monitor, FC-2091 manufactured by EIZO NANAO CORPORATION

### 8. Description of Device

RadiForce G20 is 20.1 inches monochrome monitor for medical use. This model has specification of resolution in 1600 x 1200 or 1200 x 1600 and is certified for IEC60601-1 of medical safety standard.

### 9. Intended Use

20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.

- 10. Comparison of technological characteristics between new device and predicate device Please refer to Attachment 1.
- 11. Compliance standards Plaaco rafar to Attachmont 1

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Appendix 1: Comparison table with predicate device

| Items | FC-2091 | G20 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K022109 | |
| Panel Size and Type | 53 cm (20.8") TFT monochrome LCD panel | 51 cm (20.1") TFT monochrome LCD panel |
| Pixel Pitch | 0.207 mm x 0.207 mm | 0.255 mm x 0.255 mm |
| Available Cabinet Colors | Black | Black |
| Display Colors | 1.531 grayscale tones | 1.531 grayscale tones |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° |
| Scanning Frequency (H, V) | 92.86 - 96.72Hz, 60Hz | Digital: 31.5 kHz – 75kHz, 60 Hz (VGA Text: 70Hz) |
| Native Resolutions | 2048 x 1536 (landscape),<br>1536 x 2048 (portrait) | 1600 x 1200 (landscape),<br>1200 x 1600 (portrait) |
| Brightness | 650 cd/m² | 700 cd/m² |
| Contrast Ratio | 600 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 132MHz | Digital: 162MHz |
| Response Time | 50 ms (typical) | 30 ms (typical) |
| Input Signals | DVI Standard 1.0 | DVI Standard 1.0 |
| Input Terminals | DVI-D 24 pin | DVI-D 29 pin |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 1.1 | 1 upstream, 2 downstream / Rev. 1.1 |
| Serial Ports | D-Sub 9 pin (Remote Out),<br>Min DIN 6 pin (Remote In)<br>Min DIN 8 pin (Photo Sensor) | D-Sub 9 pin (Remote Out),<br>Mini DIN 6 pin (Remote In)<br>Mini DIN 8 pin (Photo Sensor) |
| Active Display Size (H x V) | 424 mm x 318 mm<br>(16.7" x 12.5") | 408 mm x 306 mm<br>(16.1" x 12.0") |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 510 mm (20.1") (diagonal) |
| Power | 10V-120V/200V-240V, 50/60Hz, 0.7A-0.4A, 0.4-0.2A | 10V-120V/200V-240V, 50/60Hz, 0.65A-0.4A, 0.35A-0.2A |
| Power Management | DVI-DMPM | DVI-DMPM |
| Power Consumption | 70 watts (typical) | 55 watts (typical) |
| Power Save Mode | Less than 15 watts | Less than 8 watts |
| Dimensions (W x H x D) | With Stand:<br>368 mm x 520 – 592mm x 209 mm<br>(14.5" x 20.5" x 23.3" x 8.2")<br>Without Stand:<br>368 mm x 474 mm x 84 mm<br>(14.5" x 20.5" x 23.3" x 8.2") | With Stand:<br>449 mm x 456 – 528 mm x 209 mm<br>(17.7" x 18.0" x 20.8" x 8.2")<br>Without Stand:<br>449 mm x 347 mm x 86.5 mm<br>(17.7" x 13.7" x 3.4") |
| NET Weight | With Stand: 9.5 kg (20.9 lbs),<br>Without Stand: 6.3 kg (13.9 lbs) | With Stand: 10.5 kg (23.1 lbs),<br>Without Stand: 7.3 kg (16.1lbs) |
| Certifications & Standards | TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, | TUV/GM, c-TUV, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, |
| | VCCI-A, FDA 510(k) | TUV/S, VCCI-A |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Eizo Nanao Corportaion % Mr. Akira Wakayama Safety Department Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-05, JAPAN

Re: K030347

Trade/Device Name: 20.1" Monochrome LCD Monitor, RadiForce G20 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: January 29, 2003 Received: February 3, 2003

Dear Mr. Wakayama:

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 (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); 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 1000-1050.

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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, permits 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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January 27, 2003

# STATEMENT OF INDICATIONS FOR USE

KU3034 510(k) Number (If known):

Device Name: 20.1" Monochrome LCD Monitor

Indications for Use:

20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number