AVIEW Lung Nodule CAD

GUDID 08800025300176

CORELINE SOFT CO.,LTD.

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• Primary Device ID: 08800025300176
• NIH Device Record Key: d3927ff1-fae5-4e1f-a1d0-cb506bbb0ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVIEW Lung Nodule CAD
• Version Model Number: 1.1
• Company DUNS: 689517146
• Company Name: CORELINE SOFT CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800025300176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221592

FDA Product Code

• OEB: Lung Computed Tomography System, Computer-Aided Detection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-13
• Device Publish Date: 2023-03-03

Devices Manufactured by CORELINE SOFT CO.,LTD.

• 08800025300152 - AVIEW: 2023-10-18
• 08800025300176 - AVIEW Lung Nodule CAD: 2023-03-13
• 08800025300176 - AVIEW Lung Nodule CAD: 2023-03-13
• 08800025300145 - AVIEW RT ACS: 2022-12-08
• 08800025300022 - AVIEW Modeler: 2021-08-17
• 08800025300039 - AVIEW LCS: 2021-08-17
• 08800025300077 - AVIEW: 2021-08-17
• 08800025300084 - AVIEW LCS: 2021-08-17
• 08800025300015 - AVIEW: 2021-08-16