AVIEW Lung Nodule CAD

GUDID 08800025300176

CORELINE SOFT CO.,LTD.

Radiology PACS software
Primary Device ID08800025300176
NIH Device Record Keyd3927ff1-fae5-4e1f-a1d0-cb506bbb0ae0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVIEW Lung Nodule CAD
Version Model Number1.1
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS108800025300176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OEBLung Computed Tomography System, Computer-Aided Detection

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-13
Device Publish Date2023-03-03

Devices Manufactured by CORELINE SOFT CO.,LTD.

08800025300237 - AVIEW CAC2024-05-03
08800025300152 - AVIEW2023-10-18
08800025300176 - AVIEW Lung Nodule CAD2023-03-13
08800025300176 - AVIEW Lung Nodule CAD2023-03-13
08800025300145 - AVIEW RT ACS2022-12-08
08800025300022 - AVIEW Modeler2021-08-17
08800025300039 - AVIEW LCS2021-08-17
08800025300077 - AVIEW2021-08-17
08800025300084 - AVIEW LCS2021-08-17

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