VOLUSON S6, VOLUSON S8


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K103649
Device Name VOLUSON S6, VOLUSON S8
Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa, 
WI 
53226

Applicant Contact bryan behn
Correspondent
GE HEALTHCARE
9900 innovation drive
wauwatosa, 
WI 
53226

Correspodent Contact bryan behn
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 12/15/2010
Decision Date 03/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No