COLOR LCD DISPLAY, MODEL RADIFORCE R22

K033466 · Eizo Nanao Corporation · LLZ · Feb 20, 2004 · Radiology

Device Facts

• Record ID: K033466
• Device Name: COLOR LCD DISPLAY, MODEL RADIFORCE R22
• Applicant: Eizo Nanao Corporation
• Product Code: LLZ · Radiology
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of Xrray or MRI, etc.

Device Story

RadiForce R22 is a color LCD monitor designed for clinical diagnostic environments. It receives video signals from medical imaging systems (e.g., X-ray, MRI) and displays them for physician review. The device functions as a high-resolution visual interface, allowing radiologists and clinicians to interpret diagnostic images. It is intended for professional use in clinical settings to support diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Color LCD monitor; intended for medical image display; 21 CFR 892.2050 (Picture archiving and communication system); Class II device.

Indications for Use

Indicated for use in displaying 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 stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiroaki Hashimoto Eizo Nanao Corporation Engineering Management Section 153 Shimokashiwano-Cho Matt0-Shi, Ishikawa-Ken 924-8566

Re: K033466 Trade/Device Name: Color LCD Display, RadiForce R22 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: January 26, 2004 Received: January 30, 2004

Dear Mr. Hashimoto:

JAPAN

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 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.

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.

FEB 2 0 2004

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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

Page 2

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## INDICAITIONS FOR USE STATEMENT

510(k) Number (If known): ___________________________________________________________________________________________________________________________________________________

Color LCD Monitor, RadiForce R22 " Device Name

Indications for Use

Color LCD Monitor, RadiForce R22 is intended to be used in displaying for diagnosis of Xrray or MRI, etc.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Prescription Use
(Per 21CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy C. Brodon
(Division Sign Off)

tive. Ahd and Radiological De 510(k) Number.