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510(k) Data Aggregation
K Number
K081752Device Name
EDGE PACS
Manufacturer
Date Cleared
2008-08-06
(47 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ASHVA TECHNOLOGIES, PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Edge PACS™ is a software device (server, web viewer, & workstation) used for diagnostic 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.
Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing 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
Edge PACS, is a software device that consists of the Radion Workstation, Edge PACS Web Viewer, and Edge PACS Server and can be used for diagnostic viewing and manipulating of 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. Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records.
Edge PACS allows medical imaging centers to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email).
Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:
- . Prevent unauthorized access of Patient Records
- . Easy search of Patient details
- Flexibility to design auto patient ID .
- Report transmission by mail .
- . Cropping of live images
- Editing of AVI/cine loops .
- . Distribution of Reports and Images in CD
- . Comparison of images between different visits of patient
- Tagging of significant images/cineloop for future references .
- Generation of statistical data from available details .
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K Number
K071602Device Name
IMAGIC V2.0
Manufacturer
Date Cleared
2007-07-23
(42 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ASHVA TECHNOLOGIES, PVT. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
iMagic v2.0™ device is software intended for viewing and diagnostic interpretation of images acquired from Ultrasound and other DICOM compliant medical imaging systems (CT, MR, CR, DR), when installed on suitable commercial standard hardware.
iMagic v2.0™ receives Ultrasound images and other modality imaging studies over a network from servers, directly from the imaging modality or from an archive (including media) utilizing both lossless (reversible) and lossy (irreversible) compression. iMagic v2.0™ does not use lossy (irreversible) compression during image handling, manipulation, or storage.
Only DICOM, for presentation, images will be captured for display and diagnosis.
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
iMagic, a software application for medical imaging centers, that allows to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email). Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:
- . Prevent unauthorized access of Patient Records
- Easy search of Patient details .
- . Flexibility to design auto patient ID
- Report transmission by mail .
- . Cropping of live images
- Editing of AVI/cine loops
- Distribution of Reports and Images in CD .
- . Comparison of images between different visits of patient
- . Tagging of significant images/cineloops for future references
- . Generation of statistical data from available details
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Ask a specific question about this device
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