X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM

Device Classification Name

system, x-ray, stationary

510(k) Number K071401
Device Name X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
Applicant
IMAGING DYNAMICS COMPANY LTD.
2340 pegasus way, ne
suite 151
calgary, 

CA

t2e 8m5

Applicant Contact shirantha samarappuli
Correspondent
IMAGING DYNAMICS COMPANY LTD.
2340 pegasus way, ne
suite 151
calgary, 

CA

t2e 8m5

Correspodent Contact shirantha samarappuli
Regulation Number 892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received 05/21/2007
Decision Date 06/22/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No