# K202229: AI Metrics

- Pathway: 510(k) (Traditional)
- Applicant: Ai Metrics, LLC
- Decided: Dec 22, 2020 after 137 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 147 ancestors in all.
No later device cites it as a predicate yet.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142647: mint Lesion, Mint Medical GmbH (2015) Summary page 5.

## Indications for use
AI Metrics is a software solution intended to be used for viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images from multiple imaging modalities and/or multiple time points. The application supports images and anatomical datasets, such as CT and MR. AI Metrics is a software only medical device to be deployed via internet software download and installed by trained AI Metrics technicians. AI Metrics enables visualization of information that would otherwise have to be visually compared disjointedly. AI Metrics provides analytical and workflow automation tools to help the user assess and document the extent of a disease and/or the response to therapy in accordance with user selected standards 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. The product is intended to be used as a workflow automation tool by trained medical professionals. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings. Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. AI Metrics is a complement to these standard procedures. AI Metrics is not to be used in mammography.

Source page: https://510kreport.com/device/K202229
Methodology: https://510kreport.com/methodology