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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, Angiographic
510(k) Number K991922
Device Name DIGITAL IMAGING SYSTEM (BSR)
Applicant
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Applicant Contact ROBERT W CALLAHAN
Correspondent
Siemens Medical Solutions USA, Inc.
2501 N. Barrington Rd.
Hoffman Estates,  IL  60195
Correspondent Contact ROBERT W CALLAHAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received06/07/1999
Decision Date 09/01/1999
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
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