ACUSON


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K111674
Device Name ACUSON
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view, 
CA 
94043 -1344

Applicant Contact shelly pearce
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received 06/15/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls