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510(k) Data Aggregation
K Number
K163158Device Name
MEDSYNAPSE Zero Footprint Viewer
Manufacturer
Date Cleared
2016-12-02
(22 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDSYNAPTIC PRIVATE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms.
Device Description
MEDSYNAPSE ZERO FOOTPRINT VIEWER allows distribution of images within and outside the Hospital. It acquires, transmits, stores, retrieves, and displays digital images and related patient information from a variety of imaging sources and communicates the information over a network. It facilitates image viewing at diagnostic, reporting, consultation, and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short- or long-term storage devices. MEDSYNAPSE ZERO FOOTPRINT VIEWER allows communication using local or wide-area networks, public communications services, systems that include modality interfaces, and gateways to healthcare facility and departmental information systems.
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