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510(k) Data Aggregation
K Number
K061418Device Name
QUANTIVA
Manufacturer
Date Cleared
2006-07-21
(60 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
TOMOGRAPHIX IP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Quantiva™is a software application intended to co-register and display 2D & 3D multimodality (CT & PET) medical images data. The medical practitioner can visualize, process, render, view, store, print and distribute DICOM 3.0 compliant medical image data within the system and/or across computer networks as distributed locations utilizing standard P.C. hardware.
The volume and linear measurement functions are intended for evaluation and quantification of tumor measurements, location/displacement study, analysis and evaluation of both hard and soft tissue. The software also supports interactive segmentation of the region of interest, automated contouring of multi-slice ROI and labeling of avoidance structures during evaluation.
Typical users of Quantiva™ are for trained professionals (including but not limited to: radiologists, clinicians and technicians). When interpreted by a trained physician, reviewed images may be used as an element for diagnosis.
The Quantiva™is indicated for use when it is necessary to acquire, record, review and distribute these images. The Quantiva™ is a prescription device. The labeling, instructions and user operations are designed for trained, licensed medical professionals.
Device Description
The Quantiva™ is a Class II software application intended to co-register anddisplay fused PET plus CT images enabling a qualified radiological technological technologist to visualize 2D & 3D multimodal (CT and PET) medical image data. The qualified user may process, render, view, store, and print DICOM 3.0 compliant medical image data within the system and/or across computer networks utilizing standard P.C. hardware and software.
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