AccessGUDID - DEVICE: IMAGEGRID RADIOLOGY VIEWER SYSTEM (B193IG4H0)

GUDID

Device Identifier (DI) Information

Brand Name: IMAGEGRID RADIOLOGY VIEWER SYSTEM
Version or Model: IG-4H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CANDELIS, INC.

Primary DI Number: B193IG4H0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079219983 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41670	Radiological PACS software	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7c3ef815-f192-455f-93d9-e331de71102b
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: September 25, 2018