MAGNETOM AERA AND MAGNETOM SKYRA


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K111242
Device Name MAGNETOM AERA AND MAGNETOM SKYRA
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 892.1000
Classification Product Code
LNH  
Date Received 05/03/2011
Decision Date 11/23/2011
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