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 Interventional Fluoroscopic X-Ray System
510(k) Number K203281
Device Name Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
Applicant
Medphoton GmbH
Karolingerstraße. 16
Salzburg,  AT 5020
Applicant Contact Daniel Schaffarzick
Correspondent
Medphoton GmbH
Karolingerstraße. 16
Salzburg,  AT 5020
Correspondent Contact Daniel Schaffarzick
Regulation Number892.1650
Classification Product Code
OWB  
Date Received11/06/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-