ACUSON X300 ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K072676
Device Name ACUSON X300 ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view, 
CA 
94039 -7393

Applicant Contact martina vogt
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 shorebird way
mountain view, 
CA 
94039 -7393

Correspodent Contact martina vogt
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DQO   ITX   IYN  
Date Received 09/21/2007
Decision Date 12/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls