AXIS-V MONOCHROME 5 MP DISPLAY

K063066 · National Display Systems · LLZ · Aug 3, 2007 · Radiology

Device Facts

• Record ID: K063066
• Device Name: AXIS-V MONOCHROME 5 MP DISPLAY
• Applicant: National Display Systems
• Product Code: LLZ · Radiology
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.

Device Story

AXIS-V 5MP Monochrome Display is a high-resolution LCD diagnostic monitor; used by trained medical practitioners in clinical settings for review and analysis of digital medical images, including digital mammography. Device receives digital image data from external imaging systems; displays images for visual interpretation by clinicians. Facilitates clinical decision-making by providing high-resolution visualization of radiological data.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

High-resolution Liquid Crystal Display (LCD); monochrome; electronic capabilities for medical image review.

Indications for Use

Indicated for trained medical practitioners to display and view digital images, including digital mammography, for clinical review and analysis.

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

• Coronis 5MP (Barco) (K042221)
• RadiForce G51 (Eizo Nanao) (K042755)

Submission Summary (Full Text)

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K063066

AUG - 3 2007

:

## 510(k) SUMMARY

| A. Manufacturer: | National Display Systems, LLC<br>16245 Vineyard Boulevard<br>Morgan Hill, CA 95037<br>USA |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Submitted By: | Ron Hansen<br>Chief Technical Officer<br>National Display Systems, LLC |
| C. Date of Preparation: | August 24, 2006 |
| D. Contact Information: | Tel: [phone]<br>Fax: [phone] |
| E. Classification: | System, image processing, radiological |
| F. Common Name: | Monitor, display, and others |
| G. Proprietary Name: | AXIS-V 5MP Monochrome Display |
| H. Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| I. Substantial Equivalence: | Coronis 5MP (Barco) K042221<br>RadiForce G51 (Eizo Nanao) K042755 |
| J. Device Description: | The AXIS-V 5MP Monochrome Display is a<br>diagnostic display. |
| K. Intended Use: | The AXIS-V 5MP Radiological Monochrome<br>Medical Display is intended to be used to<br>display and view digital images, including<br>digital mammography, for review and analysis<br>by trained medical practitioners. |
| L. Technological Characteristics: | The AXIS-V 5MP Monochrome Display is a<br>high-resolution Liquid Crystal Display (LCD)<br>with electronic capabilities used for the review<br>and analysis of high-resolution medical<br>images by trained medical practitioners. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The symbol in the center consists of three stylized wave-like lines that appear to be stacked on top of each other.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 3 2007

National Display Systems % Ms. Denise Leung Klinker Staff Engineer / 510(k) Reviewer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K063066

Trade/Device Name: AXIS-V 5 MP Radiology Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2007 Received: July 24, 2007

## Dear Ms. Klinker: -

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 (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.

Image /page/1/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".

locting and Promoting Public He

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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 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 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" (21CFR 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): NIA

K063064

Device Name: AXIS-V 5MP Radiology Medical Display

Indications for Use:

The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valer Remer

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

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