InferRead Lung CT.AI

GUDID 00850003095042

InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.

Infervision Medical Technology Co., Ltd

X-ray image interpretive software

• Primary Device ID: 00850003095042
• NIH Device Record Key: 462153a3-9f13-49d3-aa20-171cba5efc86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InferRead Lung CT.AI
• Version Model Number: 5.0.2.5
• Company DUNS: 551093752
• Company Name: Infervision Medical Technology 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003095042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240554

FDA Product Code

• OEB: Lung Computed Tomography System, Computer-Aided Detection

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: 2025-06-02
• Device Publish Date: 2025-05-23