BIOGRAPH HD FAMILY


Device Classification Name

system, tomography, computed, emission

510(k) Number K081453
Device Name BIOGRAPH HD FAMILY
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation dr.
knoxville, 
TN 
37932

Applicant Contact alaine medio
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation dr.
knoxville, 
TN 
37932

Correspodent Contact alaine medio
Regulation Number 892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received 05/23/2008
Decision Date 06/23/2008
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