MOBINEURO Alita Intraoperative MRI System

by Sino Canada Health Engineering Research Institute (Hefei)

510(k) K223875

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K223875↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK223875	Date20 Mar 2023Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K223875
FDA Product Code: LNH

Device Class: Class II
Regulation: 21 CFR Part 892.1000
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MOBINEURO Alita Intraoperative MRI System is a mobile magnetic resonance imaging device designed for real-time intraoperative imaging. It enables surgeons to visualize brain structures and guide procedures without transferring the patient to a separate MRI suite, facilitating precision during neurosurgical interventions.

This system is intended for use in operating rooms equipped for neurosurgery and is supplied as a complete, mobile unit. The device is classified under 21 CFR 892.1000 and holds FDA 510(k) clearance (K223875), determined to be substantially equivalent through the Radiology Advisory Committee review. It is not specified as single-use or reusable, nor are MRI safety classifications or sterility details provided in the available data.