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510(k) Data Aggregation
K Number
K090481Device Name
DEMASQ IMAGING SPFTWARE DEVICE
Manufacturer
Date Cleared
2009-03-19
(23 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DEMASQ LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DEMASQ Imaging Software Device™ is a software device that receives medical images and data from various imaqing sources (including but not limited to CT. MR. US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images and data can be stored. communicated, processed and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography.
Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
Device Description
DEMASQ Imaging Software Device™ (DISD) is a user network and or a web-based PACS DICOM viewing software running on an IBM Compatible PC with a Windows 98 SE, Windows NT 4.0 (with SP 5 or later), XP or Vista operating system.
DISD is adapted for, storing, processing, routing and report generating. DISD supports the DICOM standard. To assist interpretation a user-friendly interface will allow the enduser to color, crop, zoom, rotate, measure and save the image. Images can be saved to a desktop or network as a standard file format.
DISD allows users to take full advantage of the radiographic images from digital X-ray and various modalities in order to obtain invaluable mission critical diagnostic data and images.
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