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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, Stationary
510(k) Number K081722
Device Name YSIO
Applicant
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Ms E-50
Malvern,  PA  19355
Applicant Contact GARY JOHNSON
Correspondent
Siemens Medical Solutions USA, Inc.
51 Valley Stream Pkwy.
Ms E-50
Malvern,  PA  19355
Correspondent Contact GARY JOHNSON
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/18/2008
Decision Date 08/22/2008
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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