SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K081148
Device Name SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 shorebird way
p o box 7393
mountain view, 
CA 
94039 -7393

Applicant Contact sheila pickering
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 shorebird way
p o box 7393
mountain view, 
CA 
94039 -7393

Correspodent Contact sheila pickering
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 04/22/2008
Decision Date 12/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls