SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K121434
Device Name SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
mail code d02
malvern, 
PA 
19355

Applicant Contact michelle l byrne
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
mail code d02
malvern, 
PA 
19355

Correspodent Contact michelle l byrne
Regulation Number 892.1000
Classification Product Code
LNH  
Subsequent Product Codes
LNI   MOS  
Date Received 05/14/2012
Decision Date 11/05/2012
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