AVIEW CAC

GUDID 08800025300367

CORELINE SOFT CO.,LTD.

Radiological PACS software

• Primary Device ID: 08800025300367
• NIH Device Record Key: 0fd7069f-dc4e-427f-93ca-3a94a7d185e7
• 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	08800025300367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243696

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: 2025-04-01
• Device Publish Date: 2025-03-24

On-Brand Devices [AVIEW CAC]

• 08800025300237: 2.0
• 08800025300367: 2.0