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510(k) Data Aggregation
K Number
K070954Device Name
PATIENTGALLERY IMAGING SOFTWARE
Manufacturer
Date Cleared
2007-04-20
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RASTER BUILDERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PatientGallery is a Windows-based image management system indicated for use primarily by dentists to acquire, archive, display, edit, print, email, and import/export digital images.
Device Description
PatientGallery Imaging Software is a Windows-based image management database, or system used primarily by Dentists for the indications of acquiring, archiving, displaying, editing, printing, emailing, and importing or exporting digital images.
The database is organized like a file cabinet by patient folder accommodates grayscale and color images which may also include textual and graphic notes and annotations. Images may be assembled into layouts which can be customized as required. Optional modules provide editing and viewing functions.
Image acquisition from x-ray sensors, intra-oral video cameras, digital cameras and flatbed scanners can be distributed among several workstations. The software provides direct interfaces to many industry standard devices through OEM toolkits. PatientGallery Imaging Software uses standard Windows peer-to-peer networking. By default, images are stored in the native format provided by the hardware manufacturers. PatientGallery Imaging Software may be invoked by other practice management applications so that specific patient information is accessed.
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