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510(k) Data Aggregation
K Number
K182572Device Name
InstaRISPACS / InstaZFP / InstaMobi v5.0
Manufacturer
Date Cleared
2019-04-12
(206 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Meddiff Technologies Pvt. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
InstaRISPACS / InstaZFP / InstaMobi is a software device (Enterprise Server, Diagnostic Workstation, Physician Zerofoot print Viewer and a Mobile Viewer) used for viewing and manipulating 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 sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS modules 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 cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
InstaRISPACS / InstaZFP / InstaMobi is not intended for diagnostic image review or diagnostic use on mobile devices.
Device Description
InstaRISPACS / InstaZFP / InstaMobi, is a software 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.
- . InstaRISPACS, is a server-based application for use by Physicians, which comes with the Diagnostic Viewer.
- InstaZFP, is a Zero Foot print viewer for use by Physicians to display images after ● fetching them from the InstaRISPACS server.
- . InstaMobi, is a Mobile application (for iOS & Android), for use by Physicians to fetch images from InstaRISPACS and display them on the mobile device.
In addition, InstaRISPACS, 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.
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