Lunit INSIGHT DBT

GUDID 08800076000148

Lunit Inc.

X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software X-ray image interpretive software

• Primary Device ID: 08800076000148
• NIH Device Record Key: d5c55f38-2f27-4da3-bb66-00a7096d09ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lunit INSIGHT DBT
• Version Model Number: 1.0
• Company DUNS: 690102406
• Company Name: Lunit Inc.
• 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: true
• 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	08800076000148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231470

FDA Product Code

• QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [Lunit INSIGHT DBT]

• 08800076000148: 1.0
• 08800076000162: 1.1