AVIEW

GUDID 08800025300152

CORELINE SOFT CO.,LTD.

Radiological PACS software

• Primary Device ID: 08800025300152
• NIH Device Record Key: 9f7ae6fa-1f9c-4303-9a2f-0e5e7b6e3c15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVIEW
• 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	08800025300152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214036

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-01-09

On-Brand Devices [AVIEW]

• 08800025300015: 1.0
• 08800025300077: 1.0
• 08800025300152: 1.1