510(k) · Cleared
ClearedEpione
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 Feb 24, 2022 as substantially equivalent to K132108 (Perfint Healthcare Pvt, Ltd., 2014) after a 272-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Feb 24, 2022
- Review
- 272 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001284 (2000). 5 ancestors in all, the oldest K974513 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 2 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 1 generation backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- This deviceK211645 EpioneQuantum Surgical Sas · 2022
- Descendant · cites it directly · 0 of its ownK223758 EpioneQuantum Surgical Sas · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K223758EpioneQuantum Surgical Sas · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −2 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −1 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| 0 (this device) | K211645 | Epione | Quantum Surgical Sas | 2022 | — |
| +1 | K223758 | Epione | Quantum Surgical Sas | 2023 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K132108 | MAXIOSummary page 4…ion Name: Computed tomography X-ray system (21 CFR 892.1750) Regulatory Class: II Product Code: JAK Predicate Device MAXIO (JAK, K132108), Perfint Healthcare Pvt. Ltd., Reference Device: CAS-One IR (JAK, K152473), CAScination AG Device Descrip… | 2014 |
| † | K152473 | CAS-One IR | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223758 | Epione | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K223758 (Quantum Surgical Sas, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K132108.
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. 2022, 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 procedures. 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…
Read the full statement (137 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 procedures.
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.
The device is indicated for use in liver ablation procedures under general anesthesia with rigid straight instruments such as needles and probes of diameters ranging from 11G to 19G by physicians trained for CT procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211645: Epione.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211645
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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