IMAGEGRID RADIOLOGY VIEWER SYSTEM

GUDID B193IG3HX0

ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, commu

CANDELIS, INC.

Radiology picture archiving and communication system application software
Primary Device IDB193IG3HX0
NIH Device Record Key79b964d7-a7ed-427a-b1f1-2a78e39db1de
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAGEGRID RADIOLOGY VIEWER SYSTEM
Version Model NumberIG-3H-X
Company DUNS079219983
Company NameCANDELIS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com
Phone18888008600
Emailsupport@candelis.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB193IG3HX0 [Primary]

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-26
Device Publish Date2018-09-25

On-Brand Devices [IMAGEGRID RADIOLOGY VIEWER SYSTEM]

B193IMD3203B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IMD3202B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IMD3201B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IMD2B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
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B193IGUHPR1HRX0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGUHPR1HRSAASX0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGUHPR1HRSAAS0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGUHPR1HR0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGUHPR1BDR0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGUHPR1B0The ImageGrid® PACS is a software system intended for professional use only, by prescription in
B193IGLT1R2HX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HDRX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HDRSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HDRSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2HDR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVRX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVRSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVRSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DVR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H3DV0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2H0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2BDR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R2B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HDRX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HDRSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HDRSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1HDR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H3DVRX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H3DVRSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H3DVRSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H3DVR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H3DV0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1H0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1BDR0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGLT1R1B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGEXP2H0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IGEXP2B0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IG9HX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IG9HSAASX0ImageGrid Radiology Viewer System is a device that receives medical images and data from various
B193IG9HSAAS0ImageGrid Radiology Viewer System is a device that receives medical images and data from various

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