SYNGO.MR NEUROLOGY


Device Classification Name

system, image processing, radiological

510(k) Number K121459
Device Name SYNGO.MR NEUROLOGY
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Applicant Contact michelle l byrne
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Correspodent Contact michelle l byrne
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/17/2012
Decision Date 06/22/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes