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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K223875
Device Name MOBINEURO Alita Intraoperative MRI System
Applicant
Sino Canada Health Engineering Research Institute (Hefei)
Ltd. (Scheri)
Bldg. B5, National Health Industrial Park, High-Tech Zone
Hefei,  CN 230088
Applicant Contact Gong Zhang
Correspondent
Clinical Development Solutionss
4-1250 Waverley St.
Winnipeg,  CA R3T 6C6
Correspondent Contact Danijela Domljanovic
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/23/2022
Decision Date 03/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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