AVIEW CAC

GUDID 08800025300237

CORELINE SOFT CO.,LTD.

Radiological PACS software

• Primary Device ID: 08800025300237
• NIH Device Record Key: 0a3b111c-bd56-41e8-9612-4e3bc1c8a54a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVIEW CAC
• Version Model Number: 2.0
• 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	08800025300237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233211

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2024-05-03
• Device Publish Date: 2024-04-25

Devices Manufactured by CORELINE SOFT CO.,LTD.

• 08800025300237 - AVIEW CAC: 2024-05-03
• 08800025300237 - AVIEW CAC: 2024-05-03
• 08800025300152 - AVIEW: 2023-10-18
• 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