# K251901: Magnifico Open (100009900)

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Mar 5, 2026 after 258 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: 22 generations back to K911667 (1991). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910), Esaote, S.p.A. (2024) 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 calf, knee, ankle, foot, thigh, hand, wrist, forearm, elbow, arm, shoulder, hip, lumbar column, sacral column, cervical column, thoracic spine, pelvis, temporomandibular joint (included only for "Open" configuration), head (included only for "Open" configuration) and upper abdomen (included only for "Open" configuration under option).

Source page: https://510kreport.com/device/K251901
Methodology: https://510kreport.com/methodology