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 K192574
Device Name Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Applicant
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara-shi,  JP 324-8550
Applicant Contact Paul Biggins
Correspondent
Canon Medical Systems USA
2441 Michelle Drive
Tustin,  CA  92780
Correspondent Contact Paul Biggins
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/19/2019
Decision Date 03/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-