Lunit INSIGHT MMG

GUDID 08800076000056

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

• Primary Device ID: 08800076000056
• NIH Device Record Key: 8921a5be-5a44-4ef4-ad46-8e4106a6b90f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lunit INSIGHT MMG
• Version Model Number: 1.1.6.5
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076000056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211678

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: 2022-05-06
• Device Publish Date: 2022-04-28

Devices Manufactured by Lunit Inc.

• 08800076000162 - Lunit INSIGHT DBT: 2024-04-17
• 08800076000179 - Lunit INSIGHT CXR Triage: 2024-04-17 Lunit INSIGHT CXR Triage - Windows version
• 08800076000148 - Lunit INSIGHT DBT: 2023-12-11
• 08800076000056 - Lunit INSIGHT MMG: 2022-05-06
• 08800076000056 - Lunit INSIGHT MMG: 2022-05-06
• 08800076000124 - Lunit INSIGHT CXR Triage: 2022-05-06