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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 a medical device manufactured by Sino Canada Health Engineering Research Institute (Hefei). It received FDA 510(k) clearance on 2023-03-20 under approval 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. It is manufactured by Sino Canada Health Engineering Research Institute (Hefei). The 510(k) number is K223875.

When was MOBINEURO Alita Intraoperative MRI System approved by the FDA?

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

What company makes MOBINEURO Alita Intraoperative MRI System?

MOBINEURO Alita Intraoperative MRI System is manufactured by Sino Canada Health Engineering Research Institute (Hefei).

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

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

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Related PubMed Literature

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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.

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