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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 K233748
Device Name CIARTIC Move (VB10)
Applicant
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern,  PA  19355
Applicant Contact Patricia Jones
Correspondent
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern,  PA  19355
Correspondent Contact Patricia Jones
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received11/22/2023
Decision Date 03/15/2024
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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