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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name block, beam-shaping, radiation therapy
510(k) Number K990491
Device Name ANGIO-CT MIYABI
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Applicant Contact ALICIA BUSTOS-JUERGENSEN
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVE. SOUTH
ISELIN,  NJ  08830
Correspondent Contact ALICIA BUSTOS-JUERGENSEN
Regulation Number892.5710
Classification Product Code
IXI  
Subsequent Product Code
JAK  
Date Received02/17/1999
Decision Date 04/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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