# K223875: MOBINEURO Alita Intraoperative MRI System

- Pathway: 510(k) (Traditional)
- Applicant: Sino Canada Health Engineering Research Institute (Hefei)
- Decided: Mar 20, 2023 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MOBINEURO Alita Intraoperative MRI System is indicated for use for the head and whole body. The MOBINEURO Alita Intraoperative MRI System is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. Correspond to the distribution of protons exhibiting MR characteristics; 2. Depend on NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. Display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The MOBINEURO Alita Intraoperative MRI System will also be used during intraoperative procedures when performed in an intraoperative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment. The MOBINEURO Alita Intraoperative MRI System will also be used in a multi-room suite.

Source page: https://510kreport.com/device/K223875
Methodology: https://510kreport.com/methodology