(46 days)
No
The document describes standard image processing and analysis tools, but there is no mention of AI or ML technologies.
No
The device is a software program for controlling, displaying, processing, and saving diagnostic dental and maxillofacial images; it does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" states that VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images. The "Device Description" states that "Vix Win is a software program for general dental and maxillofacial diagnostic imaging" and explicitly mentions features like processing images "to enhance their diagnostic value" and analyzing/manipulating images "to gather additional diagnostic information". These phrases directly indicate its role in diagnosis.
No
The device description explicitly states that the software controls the capture of images from various hardware systems (scanners, sensors, cameras). While the software is a key component, it is designed to interface with and control specific hardware devices for image acquisition, making it more than just a standalone software application.
Based on the provided information, VixWin PRO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- VixWin PRO analyzes images: VixWin PRO's primary function is to control, capture, display, process, and analyze digital images from various dental imaging systems (X-ray, cameras, scanned films). It does not interact with or analyze biological samples.
- Intended Use and Device Description focus on imaging: The provided text clearly describes the device's purpose as managing and processing dental and maxillofacial diagnostic images. There is no mention of analyzing biological materials.
Therefore, VixWin PRO falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
90 LLZ, MUH
Device Description
Vix Win is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, treatment, analysis and saving of x-ray 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 .. .
Note (*): provided that the relevant hardware is available and properly configured and connected with your computer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray digital images, color images from an intraoral dental camera, digitized film images
Anatomical Site
Dental and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1800 Extraoral source x-ray system.
(a)
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.(b)
Classification. Class II.
0
EXHIBIT 2 510(k) Summary GENDEX DENTAL SYSTEMS 901 West Oakton St. Des Plaines, IL 60018-1884 1.888.275.5286 Fax 1.847.550.1322 Contact: John Miller, Director of RA/QA January 17, 2006
-
- 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
-
- 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
-
- 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 .. .
1
Note (*): provided that the relevant hardware is available and properly configured and connected with your computer.
| Description | DentalEye 2,
K012439 | KaVo ERGOcom®
/ERGOcam®
K050744 | VixWin Pro |
|--------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Implementation | Software only | Hardware and Software
supplied | Software only |
| Host platform | Intel or AMD based
Personal Computer | PC Pentium, 1800 MHz or
higher. | PC |
| Operating system | Windows 95 Windows 98
Windows ME
Windows 2000
Windows NT | Windows 2000, Windows
XP. And Microsoft .NET
Framework. | Windows 98, 2000 and
XP® |
| Host RAM | 32 MB minimum | 256 MB | 32 MB |
| Host Magnetic Storage | At least 500 MB | Sufficient hard disk space
to store imaging data.,
Usually 20 GB | 4 GB minimum, 9 GB or
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
better | PC Pentium, 1800 MHz or
higher. | Pentium 133 Mhz, 300
Mhz or faster
recommended |
| Host Monitor Size | Any VGA or better PC
color monitor | XGA or better, 15" or 19"
Touch Display. | SVGA, XGA
recommended |
| Display Resolution | Minimum 800 X 600
Recommended
1024 X 768 | Screen resolution 1024 X
768, with min. true color
depth (32 bit). | 800 x 600 true color, 1024
x 768 true color
recommended. |
| User Display Preferences | Yes | Yes | Yes |
| USB and S Video support | NO | Yes | Yes |
| Receive Images from other
Systems | Yes | Yes | Yes |
| Images Displayed | Dental X-Rays, Intraoral
Images, Extraoral Images
(face, etc) | Dental X-Rays, Intraoral
Images, Extraoral Images
(face, etc), Entertainment
(TV) for patients,
Instructional Video, Patient
Administration. | Dental X-Rays, Intraoral
Images, |
| Safety Standards | Not applicable. Software
only supplied. | UL/CSA standards for
safety met. | Not applicable. Software
only supplied. |
-
- Safety and Effectiveness, comparison to predicate device:
-
- 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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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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