# K223659: Jazz

- Pathway: 510(k) (Traditional)
- Applicant: Ai Medical AG
- Decided: Sep 22, 2023 after 290 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: 5 generations back to K061855 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192130: Icobrain, Icometrix NV (2019) Summary page 4.

## Indications for use
Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.

Source page: https://510kreport.com/device/K223659
Methodology: https://510kreport.com/methodology