NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K103416
Device Name NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM
Applicant
INFIMED, INC.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Applicant Contact jigar shah
Correspondent
INFIMED, INC.
55 northern blvd.
suite 200
great neck, 
NY 
11021

Correspodent Contact jigar shah
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received 11/22/2010
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No