LUMINOS AGILE


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K111292
Device Name LUMINOS AGILE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Applicant Contact patricia d jones
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Correspodent Contact patricia d jones
Regulation Number 892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received 05/06/2011
Decision Date 06/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls