AccessGUDID - DEVICE: Enterprise Imaging XERO Viewer (05414904242919)

GUDID

Device Identifier (DI) Information

Brand Name: Enterprise Imaging XERO Viewer
Version or Model: 8.1.1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: XDFO2
Company Name: Agfa HealthCare NV

Primary DI Number: 05414904242919
Issuing Agency: GS1
Commercial Distribution End Date: July 22, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 282853795 *Terms of Use

Device Description: No description.

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 [?]
K143397	000

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: 8e31d8c4-b97c-4d4c-b413-bb96e596072c
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: March 14, 2018