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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 K190768
Device Name ARTIS icono
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Applicant Contact Patricia D. Jones
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard 65-1A
Malvern,  PA  19355
Correspondent Contact Patricia D. Jones
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA   JAK  
Date Received03/26/2019
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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