VIX WIN PRO

K060178 · Gendex Dental Systems · MUH · Mar 10, 2006 · Dental

Device Facts

• Record ID: K060178
• Device Name: VIX WIN PRO
• Applicant: Gendex Dental Systems
• Product Code: MUH · Dental
• Decision Date: Mar 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner

Device Story

VixWin Pro is a software-only dental image management system. It interfaces with Gendex digital imaging hardware (DenOptix, Visualix/GX-S, Orthoralix DPI/DDE) and third-party devices (intraoral cameras, flatbed scanners) to acquire, display, and store images. Operated by dental staff on standard PCs, the software provides tools for image processing, enhancement, and analysis to assist in clinical diagnosis. It maintains a patient database for image storage and retrieval. By centralizing image management and providing diagnostic enhancement tools, the device aids clinicians in evaluating dental and maxillofacial conditions, potentially improving diagnostic accuracy and workflow efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by verification testing of product specifications and functional performance compared to predicate systems.

Technological Characteristics

Software-only dental image management system. Operates on standard Windows-based PCs (Windows 98, 2000, XP). Supports image acquisition via USB/S-Video interfaces from compatible X-ray sensors, scanners, and cameras. Provides image processing and database management tools. No specific hardware materials or sterilization requirements as it is a software-only device.

Indications for Use

Indicated for general dental and maxillofacial diagnostic imaging. Used by dental professionals to capture, display, process, analyze, and store digital X-ray and intraoral/extraoral camera images for diagnostic purposes.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• DentalEye 2 (K012439)
• KaVo ERGOcom®/ERGOcam® (K050744)

Submission Summary (Full Text)

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K060178

## EXHIBIT 2 510(k) Summary GENDEX DENTAL SYSTEMS 901 West Oakton St. Des Plaines, IL 60018-1884 1.888.275.5286 Fax [phone] Contact: John Miller, Director of RA/QA January 17, 2006

- 1. Identification of the Device: Proprietary-Trade Name: VixWin Pro Classification Name/Product Codes: Picture archiving and communications system, 90 LLZ or System, x-ray, extraoral source, digital Product Code MUH Common/Usual Name: Dental Image Management System
- 2. Equivalent legally marketed device: DentalEye 2, K012439 and KaVo ERGOcom®/ERGOcam® K050744.
- 3. Indications for Use (intended use): VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner
- 4. Description of the Device: Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of xray digital images from DenOptix ®, Visualix ® / GX-S, KaVo Dig eXam, Orthoralix DPI & DDE series imaging systems by Gendex ®. It can also handle other types of images acquired by digitizing film with a flat bed scanner, or color images from an intraoral or extraoral dental camera such as the AcuCam Concept IV and eZ1 series. When properly installed in your computer, VixWin lets you:
- Control scanning and intake of x-ray images from image plates with the DenOptix . scanner (*).
- Control the direct capture of x-ray images from the intraoral sensor Visualix / GX-S, 미 KaVo Dig eXam, Orthoralix DPI & DDE series systems (*).
- View and capture color images from certain cameras, such as a dental camera, via a suitable video capture card (*).
- Export and import digital images (such as those obtained by scanning a film) in several 프 standard file formats.
- Process images with dental specific tools, to enhance their diagnostic value. 제
- Analyze and manipulate images in order to gather additional diagnostic information . which may not be immediately apparent on initial visual inspection.
- Create a database of patients and easily store images in patient folders .. .

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Note (*): provided that the relevant hardware is available and properly configured and connected with your computer.

| Description | DentalEye 2,<br>K012439 | KaVo ERGOcom®<br>/ERGOcam®<br>K050744 | VixWin Pro |
|--------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Implementation | Software only | Hardware and Software<br>supplied | Software only |
| Host platform | Intel or AMD based<br>Personal Computer | PC Pentium, 1800 MHz or<br>higher. | PC |
| Operating system | Windows 95 Windows 98<br>Windows ME<br>Windows 2000<br>Windows NT | Windows 2000, Windows<br>XP. And Microsoft .NET<br>Framework. | Windows 98, 2000 and<br>XP® |
| Host RAM | 32 MB minimum | 256 MB | 32 MB |
| Host Magnetic Storage | At least 500 MB | Sufficient hard disk space<br>to store imaging data.,<br>Usually 20 GB | 4 GB minimum, 9 GB or<br>more recommended. |
| Host Floppy Drives: | Not required | Not required | Not required |
| CD ROM | Yes (for installation) | Yes (for installation) | Yes (for installation) |
| Host Processor Speed | Pentium II 233 MHz or<br>better | PC Pentium, 1800 MHz or<br>higher. | Pentium 133 Mhz, 300<br>Mhz or faster<br>recommended |
| Host Monitor Size | Any VGA or better PC<br>color monitor | XGA or better, 15" or 19"<br>Touch Display. | SVGA, XGA<br>recommended |
| Display Resolution | Minimum 800 X 600<br>Recommended<br>1024 X 768 | Screen resolution 1024 X<br>768, with min. true color<br>depth (32 bit). | 800 x 600 true color, 1024<br>x 768 true color<br>recommended. |
| User Display Preferences | Yes | Yes | Yes |
| USB and S Video support | NO | Yes | Yes |
| Receive Images from other<br>Systems | Yes | Yes | Yes |
| Images Displayed | Dental X-Rays, Intraoral<br>Images, Extraoral Images<br>(face, etc) | Dental X-Rays, Intraoral<br>Images, Extraoral Images<br>(face, etc), Entertainment<br>(TV) for patients,<br>Instructional Video, Patient<br>Administration. | Dental X-Rays, Intraoral<br>Images, |
| Safety Standards | Not applicable. Software<br>only supplied. | UL/CSA standards for<br>safety met. | Not applicable. Software<br>only supplied. |

- 5. Safety and Effectiveness, comparison to predicate device:
- 6. Conclusion: In all important respects, the VixWin Pro is substantially equivalent to one or more predicate systems, including the one named above. This is based on testing to verify compliance with product specifications.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GENDEX Dental Systems % Mr. Daniel Kamm, P.E. Principal Consultant P.O. Box 7007 DEERFIELD IL 60015

Re: K060178

MAR 1 0 2006

Trade/Device Name: VixWin Pro Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: MUH and LLZ Dated: January 19, 2006 Received: January 27, 2006

Dear Mr. Kamm:

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.

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.

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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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html

Sincerely vours.

Nancy C. Bugdon

Nancv 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): K060178

VixWin Pro Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: VixWin PRO controls capture, display, treatment, analysis and saving of Xray digital images from DenOptix®, Visualix®/GX-S, Orthoralix 9200 DPI and DDE digital imaging systems produced by Gendex. It can also handle other types of digital images, e.g. color images from an intraoral or extraoral dental camera, such as the Gendex Concept IV series, or images acquired by digitizing film with a flat bed scanner.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Squires

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

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