I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K111344
Device Name I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)
Applicant
INFIMED, INC.
121 metropolitan dr.
liverpool, 
NY 
13088

Applicant Contact catherine mulcahy
Correspondent
INFIMED, INC.
121 metropolitan dr.
liverpool, 
NY 
13088

Correspodent Contact catherine mulcahy
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received 05/12/2011
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No