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CANDELIS, INC. SXCH-SYS-5027-3DV IMAGEGRID RADIOLOGY VIEWER SYSTEM

Company Name

CANDELIS, INC.

Catalog Number

SXCH-SYS-5027-3DV

UOMs

Each

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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Additional Details

Device Identifier

B193IG2H3DV0

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

No

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	B193IG2H3DV0