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 K170813
Device Name ORTHOPANTOMOGRAPH OP 3D
Applicant
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Applicant Contact Terho Turkumaki
Correspondent
PaloDEx Group Oy
Nahkelantie 160
Tuusula,  FI 04300
Correspondent Contact Terho Turkumaki
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/17/2017
Decision Date 04/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-