# K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910)

- Pathway: 510(k) (Special)
- Applicant: Esaote, S.p.A.
- Decided: Jun 26, 2024 after 63 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). 79 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212419: Magnifico Open, Magnifico MSK, Esaote, S.p.A. (2022) Summary page 4.
- K032232: Airis Elite Magnetic Resonance Imaging Device, Hitachi Medical Systems America, Inc. (2003) Summary page 4.
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 4.

## Most influential descendants
- K251901: Magnifico Open (100009900) (2026), 0 descendants of its own

## 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 analyze MR images and other real-time imaging procedures. 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). MRI provides better soft tissue contrast than CT and can differentiate better between fat, water, muscle, and other soft tissue than CT (CT is usually better at imaging bones). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.

Source page: https://510kreport.com/device/K241133
Methodology: https://510kreport.com/methodology