SOMATOM DEFINITION, MODEL AS/AS+


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K081022
Device Name SOMATOM DEFINITION, MODEL AS/AS+
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
e-50
malvern, 
PA 
19355

Applicant Contact corrine mcleod
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
e-50
malvern, 
PA 
19355

Correspodent Contact corrine mcleod
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 04/10/2008
Decision Date 06/02/2008
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