FDA.reportPublic FDA data

IMAGEGRID RADIOLOGY VIEWER SYSTEM

Primary DI
B193IG4H3DV0
Brand
IMAGEGRID RADIOLOGY VIEWER SYSTEM
Company
CANDELIS, INC.
Model
IG-4H-3DV
Catalog number
SXCH-SYS-5073-3DV
Device description
ImageGrid Radiology Viewer System is a device that receives medical images and data from various imaging sources. Images and data can be stored, commu
Published
2018-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B193IG4H3DV0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system application softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18888008600support@candelis.com

Regulatory Flags#

DUNS number
079219983
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B193IG7B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-7B2018-02-27
B193IG7BDR0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-7B-DR2018-02-27
B193IG7H3DV0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-7H-3DVSXCH-SYS-5164-3DV2018-03-01
B193IG7HDR0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-7H-DRSXCH-DR-51642018-03-01
B193IG1B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-1B2018-11-17
B193IGEXP2B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-EXP-2B2018-11-16
B193IG10H0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H2018-09-28
B193IG10H3DVSAAS0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-3DV-SAAS2018-09-28
B193IG10H3DVSAASX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-3DV-SAAS-X2018-09-28
B193IG10H3DVX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-3DV-X2018-09-28
B193IG10HDRSAAS0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-DR-SAAS2018-09-28
B193IG10HDRSAASX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-DR-SAAS-X2018-09-28
B193IG10HDRX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-DR-X2018-09-28
B193IG10HSAAS0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-SAAS2018-09-28
B193IG10HSAASX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-SAAS-X2018-09-28
B193IG10HX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-X2018-09-28
B193IG5H0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-5H2018-09-28
B193IG5H3DVSAAS0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-5H-3DV-SAAS2018-09-28
B193IG5H3DVSAASX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-5H-3DV-SAAS-X2018-09-28
B193IG5H3DVX0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-5H-3DV-X2018-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008858Roentgen WorksBrit Systems, LLCLLZ2026-05-26
08800130400228Neurophet SCALE PETNEUROPHET Inc.LLZ2026-05-26
08800130400310Neurophet AQUANEUROPHET Inc.LLZ2026-05-26
00888118154231IPSKLS-Martin L.P.LLZ2026-05-25
05404028007006OrthoViewMaterialise NVLLZ2026-05-22
08809985659300R2GATE WindowsMegagen Implant Co. LtdLLZ2026-03-24
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.LLZ2026-03-24
05404028000861Mimics Thoracic PlannerMaterialise NVLLZ2026-03-20
17540262140255Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-03-19
08800018412008EConsole2DRTECH CorporationLLZ2026-03-17
75401622502288Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-03-17
00860010575314AS SoftwareAs Software, LLCLLZ2026-03-10
00860010575321AS SoftwareAs Software, LLCLLZ2026-03-10
04719878870009EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870108EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870122EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870191EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870276EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870290EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-03-09
17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
06971576834341uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
07350092810678Sectra Orthopedic PackageSectra ABLLZ2026-03-05
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LLZ2026-02-27
08800169200134ON3D3D ONS, INC.LLZ2026-02-19
B403IQS11004iQ-SYSTEM PACSIMAGE Information Systems Europe GmbHLLZ2026-02-19
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16