SAFIRE


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K103424
Device Name SAFIRE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream parkway, e-50
malvern, 
PA 
19355

Applicant Contact alicia bustos-juergensen
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream parkway, e-50
malvern, 
PA 
19355

Correspodent Contact alicia bustos-juergensen
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 11/22/2010
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No