AI Metrics AIM1

GUDID G090AIM11

AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements, • Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.

Ai Metrics, LLC

Radiology PACS software

• Primary Device ID: G090AIM11
• NIH Device Record Key: ed07570a-ef6b-4c8b-b220-cdba9e424d4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AI Metrics
• Version Model Number: 1
• Catalog Number: AIM1
• Company DUNS: 117218324
• Company Name: Ai Metrics, LLC
• 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: false
• 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

Customer Support Contacts

• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com
• Phone: 205-573-3332
• Email: help@aimetrics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G090AIM11 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202229

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: 2021-06-01
• Device Publish Date: 2021-05-24