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 K193102
Device Name MRIaudio PREM System with MRIview
Applicant
MRIaudio, Inc.
5909 Sea Lion Place, Suite F
Carlsbad,  CA  92010
Applicant Contact Joseph Caruso
Correspondent
MRIaudio, Inc.
5909 Sea Lion Place, Suite F
Carlsbad,  CA  92010
Correspondent Contact Joseph Caruso
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/08/2019
Decision Date 01/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-