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510(k) K223758

Epione by Quantum Surgical Sas — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2023
Date Received
December 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Other clearances by Quantum Surgical Sas

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