• 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 System, Image Processing, Radiological
510(k) Number K172418
Device Name OpenSight
Applicant
Novarad Corporation
752 East 1180 South #200
American Fork,  UT  84003
Applicant Contact Doug Merrill
Correspondent
Novarad Corporation
752 East 1180 South #200
American Fork,  UT  84003
Correspondent Contact Doug Merrill
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/10/2017
Decision Date 09/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-