510(k) · Cleared
Recalled · Class II · 2025Epione
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Surgical Sas · JAK System, X-Ray, Tomography, Computed
Cleared on May 3, 2023 as substantially equivalent to K211645 (Quantum Surgical Sas, 2022) and 1 other predicate after a 139-day review. Its family tree reaches back 4 generations to 2000. It has been recalled 2 times.
- Decided
- May 3, 2023
- Review
- 139 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001284 (2000). 6 ancestors in all, the oldest K974513 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 3 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 2 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 1 generation backK211645 EpioneQuantum Surgical Sas · 2022
- This deviceK223758 EpioneQuantum Surgical Sas · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −3 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −2 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −1 | K211645 | Epione | Quantum Surgical Sas | 2022 | — |
| 0 (this device) | K223758 | Epione | Quantum Surgical Sas | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211645 | EpioneSummary page 4…Computed tomography X-ray system (21 CFR 892.1750) Regulatory Class: II Product Code: JAK Primary Predicate Device EPIONE® (JAK, K211645), Quantum Surgical SAS Secondary Predicate Device MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd. Note… | 2022 |
| * | K132108 | MAXIOSummary page 4…Product Code: JAK Primary Predicate Device EPIONE® (JAK, K211645), Quantum Surgical SAS Secondary Predicate Device MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd. Note : This proposed new version for EPIONE, will be referred to as “EPIONE v1.0.2” to different… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2025 | Class II | Z-1927-2025 | Under Investigation by firm | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. |
| Aug 5, 2024 | Class II | Z-0037-2025 | Under Investigation by firm | Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position, during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging…
Read the full statement (134 words)
The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position, during Computed Tomography (CT) guided percutaneous ablation procedures in the abdomen, performed by physicians trained for CT procedures and performed under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G.
During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223758: Epione.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026