AVIEW LCS

GUDID 08800025300039

CORELINE SOFT CO.,LTD.

Radiology PACS software

• Primary Device ID: 08800025300039
• NIH Device Record Key: cd3b75c0-0187-445e-a6fd-a74feda2e4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVIEW LCS
• Version Model Number: 1.0
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	08800025300039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193220

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-08-17
• Device Publish Date: 2021-08-09

On-Brand Devices [AVIEW LCS]

• 08800025300084: 1.0
• 08800025300039: 1.0