5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510

K062054 · Eizo Nanao Corporation · LLZ · Oct 6, 2006 · Radiology

Device Facts

• Record ID: K062054
• Device Name: 5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Oct 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

Device Story

RadiForce GS510 is a 5-megapixel monochrome LCD monitor for high-definition medical imaging. It functions as a digital image display system for clinical environments. The device incorporates Digital Uniformity Equalizer (DUE) technology to compensate for luminance non-uniformity across the screen. It is operated by healthcare professionals to view medical images, facilitating clinical decision-making in diagnostic workflows, including digital mammography. The device provides high-resolution visual output to assist clinicians in interpreting medical diagnostic data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

5-megapixel monochrome LCD monitor; Digital Uniformity Equalizer (DUE) for luminance non-uniformity compensation; high-definition display resolution.

Indications for Use

Indicated for use in medical imaging applications, including digital mammography systems, where the device meets the performance specifications required by the system manufacturer.

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

• 5 Megapixel Monochrome LCD Monitor, RadiForce G51 (K042755)

Submission Summary (Full Text)

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K062054

## 510(k) Summary as required by 807.92

OCT - 6 2006

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

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

- 3. Date of Submission
July 3, 2006

- 4. Device Trade name RadiForce GS510, 5 Megapixel Monochrome LCD Monitor
- 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 | 5 Megapixel Monochrome LCD Monitor |
| Model Name | RadiForce G51 |
| 510(k) No. | K042755 |

- 8. Description of Device
RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel) medical imaging.

- 9. Intended Use
RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

- 10. Substantial Equivalence to Predicate Device
RadiForce GS510 is substantially equivalent to G51. GS510 employs the maximum resolution values same as that of G51. Additional product innovations include Digital Uniformity Equalizer (DUE), which enables compensates for luminance non-uniformity. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT - 6 2006

Eizo Nanao Corporation c/o Koji Kubo Medical Device Division Cosmos Corporation 319 Akeno, Obata-cho Ise-shi, Mie-ken, 519-0501 JAPAN

Re: K062054

Trade/Device Name: 5 Megapixel Monochrome LCD Monitor, RadiForce GS510 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system '' Regulatory Class: II Product Code: LLZ Dated: September 4, 2006 Received: September 8, 2006

## Dear Mr. Kubo:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no review a your a your we device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce asio 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 A proval), 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/1/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. The word "Centennial" is below the letters. There are three stars below the word "Centennial."

ing and Promoting Public 9

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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 1000-1050.

This letter will allow you to begin marketing your device as described in your Section \$10(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 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/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

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Indications for Use

510(k) Number (if known):

K062054

Device Name: RadiForce GS510

Indications For Use:

RadiForce GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the 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)

David b. Sygm

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.