Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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)
Building B5, National Health Industrial Park, High-tech Zone
Hefei,  CN 230088
Applicant Contact Gong Zhang
Correspondent
Clinical Development Solutionss
4-1250 Waverley Street
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
-
-