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510(k) Data Aggregation
K Number
K141451Device Name
VixWin Platinum
Manufacturer
IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC)
Date Cleared
2014-08-26
(85 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
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