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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 K221516
Device Name ARTIS icono (Ceiling Configuration)
Applicant
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Applicant Contact Patricia D. Jones
Correspondent
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern,  PA  19355
Correspondent Contact Patricia D. Jones
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA   JAK  
Date Received05/25/2022
Decision Date 07/19/2022
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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