CS-SERIES-FP WITH 3030+OPTION


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

Correspodent Contact brian j fleming
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Code
OWB  
Date Received 04/30/2012
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