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 Automated Radiological Image Processing Software
510(k) Number K202404
Device Name BoneMRI
Applicant
MRIguidance B.V
Gildstraat 91a
Utrecht,  NL 3572 EL
Applicant Contact Roel Raatgever
Correspondent
Maxis Medical
7052 Hollow Lake Way
San Jose,  CA  95120
Correspondent Contact Suji Shetty
Regulation Number892.2050
Classification Product Code
QIH  
Date Received08/21/2020
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-