# K261331: I-Genius (100019400)

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Jul 31, 2026 after 100 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K911667 (1991). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260746: S-scan Open (100001800), Esaote, S.p.A. (2026) Summary page 5.

## Indications for use
The general-purpose magnetic resonance imaging (MRI) device is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. The indications for use are the following: imaging portions of the head. Target district: skull and brain. The I-Genius device is intended to be used intraoperatively in a shielded operating room.

Source page: https://510kreport.com/device/K261331
Methodology: https://510kreport.com/methodology