Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MOBINEURO Alita Intraoperative MRI System

K-Number: K223875 · 2023-03-20

ApplicantSino Canada Health Engineering Research Institute (Hefei)
Decision Date2023-03-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBINEURO Alita Intraoperative MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K223875. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBINEURO Alita Intraoperative MRI System?

MOBINEURO Alita Intraoperative MRI System is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). The 510(k) number is K223875.

When did MOBINEURO Alita Intraoperative MRI System receive FDA 510(k) clearance?

MOBINEURO Alita Intraoperative MRI System received FDA 510(k) clearance on 2023-03-20, under 510(k) number K223875.

Who is the listed applicant for MOBINEURO Alita Intraoperative MRI System?

The FDA 510(k) record lists Sino Canada Health Engineering Research Institute (Hefei) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBINEURO Alita Intraoperative MRI System?

The FDA product code for MOBINEURO Alita Intraoperative MRI System is LNH.

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑