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 X-Ray, Tomography, Computed, Dental
510(k) Number K201382
Device Name X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
Applicant
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Applicant Contact Dario Bandiera
Correspondent
De Gotzen S.R.L.
Via Roma, 45
Olgiate Olona,  IT 21057
Correspondent Contact Dario Bandiera
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
MUH  
Date Received05/26/2020
Decision Date 11/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-