Search Results
Found 1 results
510(k) Data Aggregation
K Number
K031248Device Name
CONSULTIVA REPORT STATION, MODEL RS-1
Manufacturer
MIRAMEDICA, INC
Date Cleared
2003-06-20
(63 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MIRAMEDICA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consultiva™ Report Station is a software application intended to be used to display low resolution, non-diagnostic medical images with annotations such as regions-of-interest or CAD marks.
Device Description
The Consultiva™ Report Station (RS) is a Windows-based program that gathers digitized medical images from a specified location on hard disk, and displays those images on a monitor, with Computer Aided Detection (CAD) results (or other annotations) overlaid on top of the images. The RS provides a User Interface (UI) that allows the user to initiate the display of the images . The RS also provides the capability to print a CAD report. The primary data sources for this system include the low resolution digital images and the CAD results. The visualization of CAD and images requires no explicit requirements for user manipulation of the data (zoom, pan, window level, etc). The visualization features of the RS include: The ability to display medical images at a reduced resolution and fixed size. . . The ability to enlarge an image. The ability to display the CAD results as an overlay over the displayed digitized images. .
Ask a Question
Page 1 of 1