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510(k) Data Aggregation
K Number
K063294Device Name
TOPACS
Manufacturer
Date Cleared
2007-01-24
(84 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RADIOLOGICAL SPECIALISTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Thoth ToPACS is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems.
Lossy Compressed Mammographic Images and Digitized Film Screen Images must not be reviewed for primary Image interpretations. Mammographic Images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other specifications reviewed and accepted by FDA
Device Description
ToPACS is a stand-alone software package that is used on general purpose computing I of ACO is a bains aronivimum hardware requirements are met, the user or system integrator is free to choose his/her own hardware platform micegrator is free to enouse minage processing, measurement, communication and The soltware and is alguing to the specifications that are documented in a Storage. 1011 System Test Plan. Testing is an integral part of Thoth software Thours Process. The software does not contact the patient, nor does it control any life-sustaining devices. A physician has ample opportunity for competent human intervention while interpreting images and clinical information.
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