DEVICE: Enterprise Imaging Xero Viewer (05414904218532)

Device Identifier (DI) Information

Enterprise Imaging Xero Viewer
Enterprise Imaging Xero Viewer 8.1
In Commercial Distribution
5873H
Agfa HealthCare NV
05414904218532
GS1

1
282853795 *Terms of Use
ENT IMG SW XERO VIEWER 8.1
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiology picture archiving and communication system application 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. It is designed specifically for use within radiology.
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FDA Product Code

[?]
Product Code Product Code Name
LLZ System, image processing, radiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143397 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

005c3fef-3dd7-4c15-b076-535544e1d2cf
September 24, 2018
4
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
+1(877)777-2432
salesinfo@agfa.com
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