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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 K232344
Device Name Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
Applicant
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact Hubert Welsch
Correspondent
GE Medical Systems SCS
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Hubert Welsch
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA   OXO  
Date Received08/04/2023
Decision Date 10/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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