AmCAD UT Detection UT-0222-1Q

GUDID 04719875621130

AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required.

AMCAD BIOMED CORPORATION

Ultrasound imaging system application software

• Primary Device ID: 04719875621130
• NIH Device Record Key: db0ca405-9857-4fd5-9214-e9adfa49e5e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmCAD UT Detection
• Version Model Number: 2.2
• Catalog Number: UT-0222-1Q
• Company DUNS: 656738726
• Company Name: AMCAD BIOMED CORPORATION
• 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: true
• 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	04719875621130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180006

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: 2020-09-04
• Device Publish Date: 2020-08-27