IMAGEGRID RADIOLOGY VIEWER SYSTEM

Primary DI
B193IG3H3DV0
Brand
IMAGEGRID RADIOLOGY VIEWER SYSTEM
Company
CANDELIS, INC.
Model
IG-3H-3DV
Catalog number
SXCH-SYS-5055-3DV
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, 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.
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
B193IG3H3DV0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

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
B193IMD1B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIMD-1B2018-09-28
B193IMD3B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIMD-3B2018-09-28
B193IG10B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10B2018-02-27
B193IG10BDR0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10B-DR2018-02-27
B193IG10H0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H2018-09-28
B193IG10H3DV0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-3DVSXCH-SYS-5437-3DV2018-02-28
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
B193IG10HDR0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-10H-DRSXCH-DR-54372018-02-28
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
B193IG1B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-1B2018-11-17
B193IG2B0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-2B2018-02-27
B193IG2BDR0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-2B-DR2018-02-27
B193IG2BTT0IMAGEGRID RADIOLOGY VIEWER SYSTEMIG-2B-TT2018-02-27

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