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 K232030
Device Name Ingenia Elition R5.7.1 SP4 MR Systems
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Applicant Contact Ioana Ulea
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 6
Best,  NL 5684PC
Correspondent Contact Ioana Ulea
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received07/07/2023
Decision Date 08/02/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-