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 K201039
Device Name HepaFat-AI
Applicant
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood,  AU 6100
Applicant Contact Alison Laws
Correspondent
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood,  AU 6100
Correspondent Contact Alison Laws
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/20/2020
Decision Date 12/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-