# K220349: TeraRecon Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Terarecon,Inc.
- Decided: Aug 12, 2022 after 186 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: 12 generations back to K971684 (1997). 80 ancestors in all.
No later device cites it as a predicate yet.
2 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200750: Neuro.Al Algorithm, Terarecon,Inc. (2020) Summary page 4.

## Indications for use
The TeraRecon Neuro Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The TeraRecon Neuro Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with, or utilized by other DICOM-compliant systems and results. The TeraRecon Neuro Algorithm provides analysis capabilities for functional, dynamic, and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment, tissue blood volume, and other parametric maps with or without the ventricles included in the calculation. The algorithm also include volume reformat in various orientation, rotational MIP 3D batch while removing the skull. This “tumble view” allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review. The results of the TeraRecon Neuro Algorithm can be delivered to the end-user through image viewers such as TeraRecon’s Aquarius Intuition system, TeraRecon’s Eureka Al Results Explorer, TeraRecon’s Eureka Clinical Al Platform, or other image viewing systems like PACS that can support DICOM results generated by the TeraRecon Neuro Algorithm. The TeraRecon Neuro Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

Source page: https://510kreport.com/device/K220349
Methodology: https://510kreport.com/methodology