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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K211645
Device Name Epione
Applicant
Quantum Surgical Sas
Zac Eureka 1000 Rue Du Mas De Verchant
Montpellier,  FR 34000
Applicant Contact Lagacherie Elise
Correspondent
Quantum Surgical Sas
Zac Eureka 1000 Rue Du Mas De Verchant
Montpellier,  FR 34000
Correspondent Contact Elise Lagacherie
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/28/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Clinical Trials NCT04230642
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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