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 K210611
Device Name MAGNETOM Free.Max
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Applicant Contact Andrew Turner
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, Mailcode 65-1A
Malvern,  PA  19355
Correspondent Contact Andrew Turner
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received03/01/2021
Decision Date 07/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-