Epione

System, X-ray, Tomography, Computed

Quantum Surgical SAS

The following data is part of a premarket notification filed by Quantum Surgical Sas with the FDA for Epione.

Pre-market Notification Details

• Device ID: K211645
• 510k Number: K211645
• Device Name: Epione
• Classification: System, X-ray, Tomography, Computed
• Applicant: Quantum Surgical SAS ZAC Eureka 1000 Rue Du Mas De Verchant Montpellier, FR 34000
• Contact: Lagacherie Elise
• Correspondent: Elise Lagacherie; Quantum Surgical SAS ZAC Eureka 1000 Rue Du Mas De Verchant Montpellier, FR 34000
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-28
• Decision Date: 2022-02-24