(301 days)
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.
The AXIS-V 5MP Monochrome Display is a diagnostic display.
The AXIS-V 5MP Monochrome Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
The provided text is a 510(k) summary for a medical display device, the AXIS-V 5MP Monochrome Display. It does not contain information about acceptance criteria, study data, sample sizes, expert ground truth establishment, or any comparative effectiveness studies as requested in your prompt. This document serves as a regulatory submission for premarket notification, establishing substantial equivalence to existing devices rather than detailing performance study outcomes.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:
- Manufacturer and Contact Information: National Display Systems, LLC.
- Device Description: AXIS-V 5MP Monochrome Display, a high-resolution Liquid Crystal Display (LCD) for viewing medical images, including digital mammography.
- Intended Use: To display and view digital images for review and analysis by trained medical practitioners.
- Classification and Product Code: 21 CFR 892.2050/Procode 90LLZ (Picture archiving and communications system).
- Substantial Equivalence: Claimed against Coronis 5MP (Barco) K042221 and RadiForce G51 (Eizo Nanao) K042755.
- FDA Communication: A letter from the FDA acknowledging review of the 510(k) and determining substantial equivalence, allowing the device to be marketed under general controls.
To provide the information you're looking for, I would need a different document, such as a clinical study report, a detailed performance evaluation report, or a more comprehensive technical submission that outlines the testing and validation performed on the device.
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AUG - 3 2007
:
510(k) SUMMARY
| A. Manufacturer: | National Display Systems, LLC16245 Vineyard BoulevardMorgan Hill, CA 95037USA |
|---|---|
| B. Submitted By: | Ron HansenChief Technical OfficerNational Display Systems, LLC |
| C. Date of Preparation: | August 24, 2006 |
| D. Contact Information: | Tel: 408-776-0085Fax: 408-776-9878 |
| 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) K042221RadiForce G51 (Eizo Nanao) K042755 |
| J. Device Description: | The AXIS-V 5MP Monochrome Display is adiagnostic display. |
| K. Intended Use: | The AXIS-V 5MP Radiological MonochromeMedical Display is intended to be used todisplay and view digital images, includingdigital mammography, for review and analysisby trained medical practitioners. |
| L. Technological Characteristics: | The AXIS-V 5MP Monochrome Display is ahigh-resolution Liquid Crystal Display (LCD)with electronic capabilities used for the reviewand analysis of high-resolution medicalimages 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 (800) 638-2041 or (240) 276-3150
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
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 _
Page 1 of 1 .
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).