K211645 is an FDA 510(k) clearance for the Epione. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.
Submitted by Quantum Surgical Sas (Montpellier, FR). The FDA issued a Cleared decision on February 24, 2022 after a review of 272 days - an extended review cycle.
This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.
View all Quantum Surgical Sas devices
NCT04230642
Completed
Interventional
Industry-sponsored
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement
| Condition studied |
Hepatic Tumor |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Months+
|
| Principal investigator |
Boris Guiu, MD |
| Sponsor |
Quantum Surgical
(industry)
|
Started 2020-05-25
→
Primary completion 2021-02-02
Primary outcome
Evaluation of the safety related to the procedure
Secondary outcome
Evaluation of the accuracy of the device
Study completed - no results published.
This trial concluded in 2021 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov