COLOR LCD MONITOR, MODEL RADIFORCE RX211

K080457 · Eizo Nanao Corporation · LLZ · Mar 20, 2008 · Radiology

Device Facts

• Record ID: K080457
• Device Name: COLOR LCD MONITOR, MODEL RADIFORCE RX211
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.

Device Story

RadiForce RX211 is a 21.3-inch color LCD monitor for medical image viewing. Device receives digital image data from medical workstations; displays high-definition images for diagnostic review by trained medical practitioners. Operates in clinical environments. Improved brightness (750 cd/m2 vs 600 cd/m2) and contrast compared to predicate RX210. Facilitates clinical decision-making by providing high-resolution visualization of X-ray and MRI studies. Does not support mammography.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing and technical specifications.

Technological Characteristics

21.3-inch color LCD monitor. Brightness: 750 cd/m2. Resolution matches predicate RX210. Software modified for performance improvements. Connectivity: standard medical workstation interface.

Indications for Use

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

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 RX210 (K063120)

Submission Summary (Full Text)

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K080457

MAR 2 0 2008

## 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 February 19, 2008

4. Device Trade name Color LCD Monitor, RadiForce RX211

### 5. Common/Usual Name

Image display system, medical image workstation, image monitor/display, and others

## 6. Classification Number

Medical displays classified in Class II per 21 CFR 892.2050.

### 7. Predicate Device

| Manufacturer | : EIZO NANAO CORPORATION |
|--------------|--------------------------|
| Device Name | : Color LCD Monitor |
| Model Name | : RadiForce RX210 |
| 510(k) No. | : K063120 |

#### 8. Description of Device

RadiForce RX211 is a 54cm (21.3") Color LCD display for medical image viewing. RX211 displays high-definition medical imaging.

### 9. Intended Use

RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.

### 10. Technological Characteristics

RadiForce RX211 is substantially equivalent to RX210. RX211 employs the maximum resolution values same as that of RX210. RX211 improved the brightness of the LCD module, and modified the software. The brightness improved in 750 cd/m2 from 600 cd/m2. The contrast improved by it.

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Hiroaki Hashimoto EIZO NANAO CORPORATION Engineering Management Section

Re: K080457

153 Shimokashiwano-cho

Hakusan Ishikawa-ken 924-8566

Manager

JAPAN

Trade/Device Name: Color LCD Monitor, (RadiForce RX211) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 19, 2008 Received: February 20, 2008

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.

MAR 2 0 2008

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.

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moting Public J

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of action that I bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or urf I vature 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 OI It Fat 607), incoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 11 you user for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's (210) of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain (1) = 1 ) = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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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Indications for Use

510(k) Number:

K080457

Color LCD Monitor, RadiForce RX211 Device Name :

Indications for Use:

RadiForce RX211 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX211 does not support the display of mammography images for diagnosis.

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)

Tore N. Pham

(Division Sign-Off)

Division of Reproductive. Abdomina and Radiological Devi 510(k) Number