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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact PATRICIA D JONES
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
IZI  
Date Received05/06/2011
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
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