LCD MONITOR, RADIFORCE G11, G31, G51

K032026 · Eizo Nanao Corporation · LLZ · Aug 27, 2003 · Radiology

Device Facts

• Record ID: K032026
• Device Name: LCD MONITOR, RADIFORCE G11, G31, G51
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used in displaying for diagnosis of X-ray or MRI, etc.

Device Story

RadiForce G11, G31, and G51 are monochrome LCD monitors designed for medical imaging. Devices receive video signals from medical imaging systems (e.g., X-ray, MRI) and display high-resolution grayscale images. Used in clinical environments by radiologists and clinicians to view diagnostic images; output facilitates clinical decision-making and diagnosis. Monitors serve as visual interfaces for diagnostic workstations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monochrome LCD monitors; sizes: 18.1 inch (G11), 20.8 inch (G31), 21.3 inch (G51). Function as diagnostic display units for medical imaging systems. Connectivity via standard video interfaces for integration with PACS workstations.

Indications for Use

Indicated for the display of medical images, including X-ray and MRI, for diagnostic purposes by healthcare professionals.

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).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

## SEP 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiroaki Hashimoto Manager, engineering Management Section Eizo Nanao Corporation 153 Shimokashiwano-cho, Matto-shi Ishikawa-ken, 924-8566 JAPAN

Re: K032026

Trade/Device Name: RadiForce G11, RadiForce G31, & RadiForce G51 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: August 4, 2003 Received: August 8, 2003

Dear Mr. Hashimoto:

This letter corrects our substantially equivalent letter of August 27, 2003 regarding the address and contact information.

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 (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

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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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

David A. Sigsmon

N
Dr

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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## June 25, 2003

## INDICAITIONS FOR USE STATEMENT

510(k) Number (If known):

. .

K032026

Device Name

46 cm (18.1 inch) Monochrome LCD Monitor, RadiForce G11 53 cm (20.8 inch) Monochrome LCD Monitor, RadiForce G31 54 cm (21.3 inch) Monochrome LCD Monitor, RadiForce G51

Indications for Use:

Monochrome LCD Monitor, RadiForce G11, G31 and G51 are intended to be used in displaying for diagnosis of X-ray or MRI, etc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21CFR 801.109)

OR

Over-The-Counter Use_

Daniel A. Lyons

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number 032024