VISIO+CD VIEWER# KPSCDVE01

K070606 · Keosys Sas · LLZ · Apr 24, 2007 · Radiology

Device Facts

• Record ID: K070606
• Device Name: VISIO+CD VIEWER# KPSCDVE01
• Applicant: Keosys Sas
• Product Code: LLZ · Radiology
• Decision Date: Apr 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography. Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM, Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

Device Story

Visio+ CD Viewer is a software component distributed on CD-ROMs alongside medical images. It functions as a DICOM viewer for image review and manipulation. Operated by trained professionals (physicians, radiologists) on standard Windows-based PCs (Pentium III, 1 GHz, 512 MB RAM). The software enables clinicians to view and manipulate images directly from the CD-ROM. It does not perform primary diagnostic interpretation, specifically excluding mammography. It facilitates clinical review of medical imaging data in point-of-care or clinical settings.

Clinical Evidence

No clinical data. Bench testing only, conducted according to a Software Test Plan as part of the manufacturer's software development process.

Technological Characteristics

Software component for Windows 2000/XP; requires Pentium III 1 GHz, 512 MB RAM, 1024x768 display, and CD/DVD drive. DICOM-compliant viewer. No specific hardware materials or energy sources; software-only device.

Indications for Use

Indicated for trained professionals, including physicians and radiologists, for viewing and manipulating medical images stored on CD-ROMs. Not for primary image interpretation in mammography.

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

• MIMviewer (K062163)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Keosys Technologies de l'information. The logo consists of a black circle with a white "K" inside, followed by the word "Keosys" in a bold, sans-serif font. Below the word "Keosys" is the phrase "TECHNOLOGIES DE L'INFORMATION" in a smaller, sans-serif font.

Image /page/0/Picture/1 description: The image shows a black and white picture of what appears to be a piece of equipment. There are some numbers on the equipment, including 01, 02, 03, 04, 05, and 06. There is also some handwritten text on the image, which is difficult to read. The image is somewhat blurry and pixelated.

APR 2 4 2007

# 510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification for Visio+ CD Viewer in conformance with 21 CFR 807.92

| Date Prepared: | January 2007. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Keosys S.A.S.<br>1, impasse Augustin Fresnel<br>Z.A. du Moulin Neuf<br>B.P. 227<br>44815 Saint-Herblain cedex<br>France |
| Contact name: | Mr. Anthony Mottier |
| Contact Email: | [e-mail] |
| Contact Telephone: | 00 33 (0)2 40 92 26 13 |
| Contact Fax: | 00 33 (0)2 40 92 26 26 |
| Device Trade Name: | Visio+ CD Viewer |
| Device Common Name: | DICOM CD Viewer |
| Device Classification Name: | Picture Archiving and Communication System |
| Classification Panel: | 21 CFR §892.2050 |
| Product code: | LLZ |
| Device Classification: | Class II |
| Predicate Device Name: | MIMviewer |
| Predicate Device Manufacturer: | MIMvista Corp. |
| Predicate Device 510(k) number: | K062163 |

### Device Description:

Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device.

Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.

#### Indications for Use:

Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography. Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM, Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

#### Testing:

Visio+ CD Viewer is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "MINISTRY OF HEALTH & HUMAN SERVICES". The graphic in the center appears to be a stylized representation of a bird or a similar symbol, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Mottier Anthony System Quality Manager Keosys S.A.S. 1, impasse Augustin Fresnel, Z.A. duMoulin Neuf Saint-Herblain, 44815 FRANCE

APR 2 4 2007

Re: K070606

Trade/Device Name: Visio+ CD Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 15, 2007 Received: March 5, 2007

Dear Mr. Anthony:

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 indiver 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 Cometic 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 (Spocial 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 black and white circular seal. The seal contains the text "1826-1926" at the top, and the word "Centennial" at the bottom. In the center of the seal are the letters "PA" in a stylized font, with three stars below the letters. The seal appears to be a commemorative emblem.

Protecting and Promoting Public Health

{2}------------------------------------------------

Page 2 -

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

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Visio+ CD Viewer.

Indications For Use:

Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography.

Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM.

Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel be. hyman

(Unsion Sign-Off) [ consion of Reproductive, Abdominal, a Factological Devices 510(k) Number

Page 1 of 1