(85 days)
No
The summary describes standard image processing and database management functionalities common in dental imaging software, with no mention of AI or ML terms or capabilities.
No
The description indicates that the device is for diagnostic imaging, controlling capture, display, enhancement, and storage of images. It does not perform any therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "VixWin Platinum is a software program for general dental and maxillofacial diagnostic imaging." Additionally, the "Device Description" mentions that it "Process images with dental specific tools to enhance their diagnostic value" and "Analyze and enhance images to gather additional diagnostic information."
Yes
The device is described as a "software program" that controls capture, display, enhancement, and saving of digital images from various digital imaging systems. It explicitly states it has "removed legacy hardware no longer supported" and focuses on software functionalities like image processing, database management, and network connectivity. While it interacts with imaging hardware, the device itself is presented solely as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VixWin Platinum's Function: VixWin Platinum is a software program that processes and manages medical images (specifically dental and maxillofacial X-rays and camera images). It does not analyze biological samples from the body.
- Intended Use: The intended use clearly states "general dental and maxillofacial diagnostic imaging," which involves interpreting images, not analyzing biological specimens.
- Device Description: The description focuses on image capture, display, enhancement, storage, and communication. There is no mention of analyzing biological samples or performing tests on them.
Therefore, VixWin Platinum falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
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.
Product codes
LLZ
Device Description
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray digital images from DenOptix®, Visualix ® /GX-S, Orthoralix9200 DPI and DDE digital imaging systems; Color images from an intraoral or extraoral dental camera; Images acquired by digitizing film with a flatbed-scanner; X-ray images from imaging plates with the Photo-Stimulable Phosphor (PSP) scanners; Direct capture of x-ray images from intra-oral sensors and extra-oral systems.
Anatomical Site
Dental and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained and qualified dentist or dental technician
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)
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).
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
§ 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).
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: sanjay.ahuja@kavokerrgroup.com Telephone: (267) 954-1463 Fax: (215) 997-5665.
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/
| 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 | ||
| Preferences | Yes | Yes |
| USB and S Video | ||
| support | Yes | Yes |
| Receive Images from | ||
| 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).