AVIEW LCS

GUDID 08800025300084

CORELINE SOFT CO.,LTD.

Radiology PACS software
Primary Device ID08800025300084
NIH Device Record Key1752ba04-acc9-4033-b64b-87b2f7590d8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVIEW LCS
Version Model Number1.0
Company DUNS689517146
Company NameCORELINE SOFT CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800025300084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [AVIEW LCS]

088000253000841.0
088000253000391.0

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