MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES

Device Classification Name

system, x-ray, tomography, computed

510(k) Number K071378
Device Name MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
Applicant
E-Z-EM, INC.
750 summa ave.
westbury, 
NY 
11590

Applicant Contact steven hartman
Correspondent
E-Z-EM, INC.
750 summa ave.
westbury, 
NY 
11590

Correspodent Contact steven hartman
Regulation Number 892.1750
Classification Product Code
JAK  
Subsequent Product Codes
DSB   IZQ  
Date Received 05/17/2007
Decision Date 06/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No