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510(k) Data Aggregation
K Number
K080334Device Name
INSTARAD
Manufacturer
MEDSPHERE TECHNOLOGIES PVT LTD.
Date Cleared
2008-02-21
(14 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDSPHERE TECHNOLOGIES PVT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InstaRad™ is a software device (DICOM Gateway Application, InstaRad Enterprise Server, and Workstation) used for viewing and manipulating medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaRad™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.
Device Description
InstaRad™ is an application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, InstaRad™ can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study of the System), providing seamless access to reports for fully-integrated electronic patient records.
InstaRad™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:
- DICOM Gateway Application is deployed at all remote centre or . hospitals. It receives images from modalities over LAN and uploads them to central server.
- Central Server runs the Web Server and Image Server and provide . study and image data to doctors.
- . WorkStation - Doctor at client side access the study list in the browser. They can select the patient and download the images.
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