BRACHYTHERAPY SOURCE DEVICE, MODEL 9011


Device Classification Name

seed, isotope, gold, titanium, platinum

510(k) Number K081066
Device Name BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
Applicant
MEDI-PHYSICS, INC., DBA GE HEALTHCARE
101 carnegie centre
princeton, 
NJ 
08540 -6231

Applicant Contact david risley
Correspondent
MEDI-PHYSICS, INC., DBA GE HEALTHCARE
101 carnegie centre
princeton, 
NJ 
08540 -6231

Correspodent Contact david risley
Regulation Number 892.5730
Classification Product Code
IWG  
Subsequent Product Code
KXK  
Date Received 04/15/2008
Decision Date 05/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No