# K212419: Magnifico Open, Magnifico MSK

- Pathway: 510(k) (Traditional)
- Applicant: Esaote, S.p.A.
- Decided: Feb 4, 2022 after 184 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: 20 generations back to K911667 (1991). 58 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161973: G-scan Brio, S-scan, Esaote, S.p.A. (2016) Summary page 4.
- K180592: G-scan Brio, Esaote, S.p.A. (2018) Summary page 4.

## Most influential descendants
- K241133: Magnifico Open (100009900); Magnifico MSK ( 100009910) (2024), 1 descendant of its own
- K251901: Magnifico Open (100009900) (2026), 0 descendants of its own

## Indications for use
The general-purpose magnetic resonance imaging (MRI) system is designed to scan any targeted area of the body, to collect, display and analyse MR images and other real-time imaging procedures. Imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic, the lumbar and the sacral sections as portions of the spinal column, imaging the pelvis and imaging the head. Outcomes related to diagnosis Magnifico is a Magnetic Resonance (MR) system that produces cross-section images of the limbs, joints, spinal column, pelvis and head. 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/K212419
Methodology: https://510kreport.com/methodology