510(k) K211645
K211645 is an FDA 510(k) premarket notification submitted by Quantum Surgical Sas for the device "Epione". The FDA issued a decision of Substantially Equivalent on February 24, 2022. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Quantum Surgical Sas has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2022
- Date Received
- May 28, 2021
- 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