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510(k) Data Aggregation
K Number
K063253Device Name
RCHIVE PACS
Manufacturer
Date Cleared
2006-12-12
(46 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
rChive™ PACS is a software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. 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
rChive™ PACS is a Picture Archival and Communication System (PACS), which facilitates image viewing at diagnostic, reporting, consultation and remote computer workstations, as well as archiving of pictures on magnetic or optical media using short or long-term storage devices. rChive™ PACS allows communication using local or wide-area networks, public communications services, systems that include modality interfaces and gateways to healthcare facility and departmental information systems.
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