RevMed

CANDELIS, INC. IG-LT1-R2H-3DV-R IMAGEGRID RADIOLOGY VIEWER SYSTEM

Company Name
CANDELIS, INC.
Catalog Number
IG-LT1-R2H-3DV-R

Description

ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. 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 technical specifications reviewed and accepted by FDA.Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
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Summary

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Additional Details

Device Identifier
B193IGLT1R2H3DVR0
Is RX
Yes
Is Over the Counter
No
Requires Sterilization
No
Is Sterile
No
Is Single Use
No

Barcode Mapping

Unit of MeasurementEachesGTIN
Each1B193IGLT1R2H3DVR0