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 K130443
Device Name I-MAX TOUCH 3D
Applicant
OWANDY
110 E. GRANADA BLVD.
SUITE 207
ORMOND BEACH,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
OWANDY
110 E. GRANADA BLVD.
SUITE 207
ORMOND BEACH,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number892.1750
Classification Product Code
OAS  
Date Received02/21/2013
Decision Date 06/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-