SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE


Device Classification Name

system, image processing, radiological

510(k) Number K111861
Device Name SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
Applicant
SIEMENS MEDICAL SYSTEMS USA
53 valley stream parkway
malvern, 
PA 
19355

Applicant Contact nadia sookdeo
Correspondent
SIEMENS MEDICAL SYSTEMS USA
53 valley stream parkway
malvern, 
PA 
19355

Correspodent Contact nadia sookdeo
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/30/2011
Decision Date 01/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes