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510(k) Data Aggregation
K Number
K141329Device Name
RADSPA
Manufacturer
Date Cleared
2014-06-20
(30 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
TELERAD TECH PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RADSpa™ components are intended to be used in hospitals, imaging centers, radiologist reading practices and by any user who requires and is granted access to view patient's images, demographic and report information.
RADSpa™ PACS is a flexible, standards-compliant, web-based, workflow management solution designed for centralized and distributed imaging environments. This device consolidates all radiology exam information including images and reports from multiple systems into a centrally managed work list, which can be accessible using any browser. RADSpa™ PACS provides complete PACS functionality used to receive and manage DICOM images and make the data available across a network. RADSpa™ viewer is used for diagnosis and Primary Image Interpretation of DICOM compliant image data derived from all modalities. This component is not intended for mobile devices.
RADSpa™ MPR/MIP/3D components are used for post-processing and is designed to assist radiologists in the diagnostic analysis, visualization, and quantification of CT and MR images. This device supports enhanced visualization and analysis techniques such as multi-planar and oblique reformats, maximum intensity projections, image averaging, subtraction and blinking of images acquired at different time points.
RADSpa™ MPR/MIP/3D is also used to perform post-processing analysis digital images from CT and MR. The software analysis tools may be applied to image subtractions, reformatted images, multi-planar reformats and maximum intensity projections. The software package includes tools to allow the radiologist to manipulate and fly-through images for enhanced visualization.
RADSpa™ MPR/MIP/3D is not intended for mobile devices.
Device Description
RADSpa™ is a software device that consists of RADSpa™ PACS and Viewer&RADSpa™ 2D/MPR/MIP/3D viewer.
RADSpa™ PACS components (server-side) enable receiving, storing and sending DICOM images and managing the workflow required for radiologists. The components are developed using .NET and runs on Windows OS. The images are stored in the file system and the workflow-related data in a RDBMS database
RADSpa MPR/MIP/3Dviewer components run on Windows OS and enable downloading of images from RADSpa™ server and viewing and manipulating of those images on the workstation
Overall features include:
- Centralized or Distributed Archive functionality
- Uses commercially available computers, servers, operating systems and network infrastructure, with expandable storage capability
- Single or Multi server options (i.e. Archive, Web Server and PACS application can reside on a single server computer)
- Pre-emptive downloading- perfecting of images in real time Web based solution
- Scalable from single practice to enterprise wide PACS
- High level of security
- DICOM, JPEG and JPEG 2000 compliant
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