VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K121063
Device Name VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
GE MEDICAL SYSTEM ISRAEL LTD.
9900 innovation dr
wauwatosa, 
WI 
53226

Applicant Contact bryan behn
Correspondent
GE MEDICAL SYSTEM ISRAEL LTD.
9900 innovation dr
wauwatosa, 
WI 
53226

Correspodent Contact bryan behn
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received 04/06/2012
Decision Date 08/21/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No