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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K062623
Device Name AXIOM LUMINOS DRF
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact GARY JOHNSON
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact GARY JOHNSON
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received09/05/2006
Decision Date 08/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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