BIOGRAPH MMR


Device Classification Name

tomographic imager combining emission computed tomography with nuclear magnetic resonance

510(k) Number K103429
Device Name BIOGRAPH MMR
Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
810 innovation drive
knoxville, 
TN 
37932

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

Correspodent Contact alaine medio
Regulation Number 892.1200
Classification Product Code
OUO  
Date Received 11/22/2010
Decision Date 06/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes

Recalls CDRH Recalls