• 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, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K121293
Device Name CS-SERIES-FP WITH 3030+OPTION
Applicant
OMEGA MEDICAL IMAGING, LLC
675 HICKMAN CIRCLE
SANFORD,  FL  32771
Applicant Contact BRIAN J FLEMING
Correspondent
OMEGA MEDICAL IMAGING, LLC
675 HICKMAN CIRCLE
SANFORD,  FL  32771
Correspondent Contact BRIAN J FLEMING
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received04/30/2012
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-