VixWin Platinum

K141451 · Imaging Sciences International (Dba Gendex, LLC) · LLZ · Aug 26, 2014 · Radiology

Device Facts

• Record ID: K141451
• Device Name: VixWin Platinum
• Applicant: Imaging Sciences International (Dba Gendex, LLC)
• Product Code: LLZ · Radiology
• Decision Date: Aug 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Device Story

VixWin Platinum is a software-only dental imaging system; operates on standard PCs running Windows OS. Inputs include digital X-ray images from intraoral/extraoral sensors, PSP scanners, and color images from dental cameras. Software controls image capture, display, enhancement, and storage; manages patient databases locally or across networked workstations. Clinicians use the software to view and process images to aid diagnostic assessment; enhances diagnostic value of images through dental-specific tools. Benefits include streamlined image management, improved diagnostic visualization, and efficient data sharing across clinical environments.

Clinical Evidence

Bench testing only. Verification and validation testing demonstrated that VixWin Platinum functions equivalently to the predicate device (K060178). No clinical data provided.

Technological Characteristics

Software-only device; runs on Windows-based PCs (Windows XP through Windows 8). Supports network connectivity for database sharing and image communication. Compatible with various digital imaging systems (sensors, PSP scanners, cameras). No hardware components; no specific safety standards applicable beyond software validation.

Indications for Use

Indicated for general dental and maxillofacial diagnostic imaging. Used by trained and qualified dentists or dental technicians for capturing, displaying, enhancing, storing, and communicating digital images.

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

• VixWin PRO (K060178)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2014

Imaging Sciences International (dba Gendex LLC, Dexis LLC) Sanjay Ahuja Director of Regulatory Affairs 1910 North Penn Road HATFIELD PA 19440

Re: K141451

Trade/Device Name: VixWin Platinum Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 1, 2014 Received: August 1, 2014

Dear Dr. Ahuja:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

FDA

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141451

Device Name VixWin Platinum

Indications for Use (Describe)

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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### 510(K) Summary

### VixWin Platinum

### Submitter's Name, Address, Telephone Number

Imaging Sciences International LLC (dba Gendex LLC, DEXIS LLC) 1910 North Penn Rd. Hatfield, PA 19440

Contact Person Sanjay Ahuja, Ph.D. Email: [e-mail] Telephone: [phone] Fax: [phone].

# Date Prepared

30 May 2014

Name of Device VixWin Platinum

### Name/Address of Sponsor

Imaging Sciences International (dba Gendex LLC) 1910 North Penn Rd. Hatfield, PA 19440

Common or Usual Name Dental Imaging Device

Product Code LLZ

Classification Name System, Image Processing, Radiology, per 21 CFR §892.2050.

# Predicate Devices

VixWin PRO (K060178)

## Intended Use / Indications for Use

VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Caution: Federal law restricts this device to sale by or on the order of a trained and qualified dentist or dental technician.

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# Technological Characteristics

The following are the technological characteristics between the proposed version of Microsoft Windows (3.3) and the cleared version of the VixWin Platinum Software (K060178).

| Component/<br>Functionality | VixWin PRO (K060178) | VixWin Platinum (Proposed) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | VixWin PRO controls capture, display, treatment, analysis and saving of X-ray digital images from DenOptix®, Visualix ® /GX-S, Orthoralix9200 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 flatbed- scanner | VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations. |
| Implementation | software only | Software only |
| Host Platform | PC | PC |
| Operating System | N/A | Windows 8 professional (32/64-bit) |
| | Windows 98, 2000, and XP ® | Windows XP professional (32-bits) |
| | N/A | Windows Vista Business (32-bits) |
| | N/A | Windows Server 2003 |
| | N/A | Windows Server 2008 |
| | N/A | Windows 7 Professional (32/64-bits} |
| Host RAM | 32MB | 1024 MB minimum, 2048MB recommended |
| Host storage | 4GB minimum, 9GB or more recommended | 30GB minimum, 200GB recommended |
| Host floppy drives | Not required | Not required |
| Installation Media | CD-ROM | DVD or Network |
| Host Processor Speed | Pentium 133 MHz, 300 MHz or faster recommended | Pentium 4 2.0 GHz min, Pentium 4 3.2 GHz recommended |
| Host Monitor Size | SVGA, XGA recommended | SVGA with 0.25/0.26 dot pitch |
| Display resolution | 800 x 600 true color, 1024 x768 true color recommended | 1024 x 768 24 bit true color min, 32 bit true color recommended |
| User Display<br>Preferences | Yes | Yes |
| USB and S Video<br>support | Yes | Yes |
| Receive Images from<br>other Systems? | Yes | Yes |
| Images Displayed | Dental X-rays, intraoral Images | Dental X-rays, intraoral and extraoral Images |
| Safety Standards | Not applicable. Software only supplied | Not applicable. Software only supplied |

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VixWin Platinum Software has the following functionality which compares with the functionality provided for VixWin PRO predicate cleared under K060178. The functionality has been updated to remove legacy hardware no longer supported by the VixWin Platinum Software.

- Controls scanning and intake of x-ray images from imaging plates with the Photo-Stimulable ● Phosphor (PSP) scanners.
- Controls the direct capture of x-ray images from intra-oral sensors and extra-oral systems. ●
- Allows View and capture color images from intra-oral and extra-oral cameras. ●
- . Export and import digital images (such as those obtained by scanning a film).
- . Process images with dental specific tools to enhance their diagnostic value.
- . Analyze and enhance images to gather additional diagnostic information which may not be immediately apparent on initial visual inspection.
- Obtaining and storing patient data pertaining to those images
- Both the viewing of the images and storage of the images and their associated data. ●
- Managing (locally and remotely) a database of patients and related data.
- Allows the update of existing patient information and the creation and storage of new patient information in a database over the network.
- . Allows access to patient files from multiple workstations via network connectivity.
- . Allows printing images and image related information over the network.

VixWin Platinum can be utilized either locally or over a networked environment. If VixWin Platinum is installed on several computers, the patient and image database can be shared among them and used from different workstations.

### Substantial Equivalence

The VixWin Platinum Software with the new proposed Indications for Use described in this submission is substantially equivalent to the VixWin PRO software cleared under K0610178 and satisfy all criteria of substantial equivalence based upon the above comparisons in the sections and do not raise new concerns in safety and effectiveness: (1) Indications for Use, (2) Technological Characteristics, and (3) Theory of Operations. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is safe and effective. All internal verification and validation has been completed.

## Performance Data

The current version of VixWin Platinum performs equivalently in functionality as the cleared Vix Win PRO (K060178). Performance data (Verification and Validation) demonstrate that VixWin Platinum functions equivalently to the predicate devices. Thus, the Vix Win Platinum (proposed) is substantially equivalent to the cleared VixWin PRO (K060178).