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 K212673
Device Name MR 5300
Applicant
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Applicant Contact Jan van de Kerkhof
Correspondent
Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best,  NL 5684PC
Correspondent Contact Jan van de Kerkhof
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LNI  
Date Received08/24/2021
Decision Date 11/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-