ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K121699
Device Name ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 east middlefield road
mountain view, 
CA 
94043

Applicant Contact shelly pearce
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
DQO   ITX   IYO  
Date Received 06/08/2012
Decision Date 06/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

No