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 K221619
Device Name ECHELON Oval V6.2 MRI System
Applicant
Fujifilm Healthcare Corporation
2-1, Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Randy Vader
Correspondent
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue
Suite 300
Lexington,  MA  02421
Correspondent Contact Kotei Aoki
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/03/2022
Decision Date 01/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-