510(k) · Cleared
ClearedXACT Robotic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xact Robotics, Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 3, 2019 as substantially equivalent to K131433 (Isys Medizintechnik GmbH, 2014) and 1 other predicate after a 140-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Oct 3, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001284 (2000). 6 ancestors in all, the oldest K974513 (1998). 3 later devices descend 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 deviceK191332 XACT Robotic SystemXact Robotics, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK201586 XACT Robotic SystemXact Robotics, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK213759 XACT Robotic System, ACE ModelXact Robotics, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK221116 XACT ACE Robotic SystemXact Robotics, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView 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) | K191332 | XACT Robotic System | Xact Robotics, Ltd. | 2019 | — |
| +1 | K201586 | XACT Robotic System | Xact Robotics, Ltd. | 2020 | — |
| +2 | K213759 | XACT Robotic System, ACE Model | Xact Robotics, Ltd. | 2022 | — |
| +2 | K221116 | XACT ACE Robotic System | Xact Robotics, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K131433 | Isys 1 (U.S),Accessory, Non-SterileSummary page 4…ame: 21 CFR 892.1750; Computed tomography X-ray system Regulatory Class: Class II Product Code: JAK Predicate Devices iSYS Medizintechnik GmbH iSYS 1 (K131433) Perfint Healthcare Pvt. Ltd. Maxio (K132108) Device Description The XACT Robotic System is a user-controlled positioning… | 2014 |
| * | K132108 | MAXIOSummary page 4…ray system Regulatory Class: Class II Product Code: JAK Predicate Devices iSYS Medizintechnik GmbH iSYS 1 (K131433) Perfint Healthcare Pvt. Ltd. Maxio (K132108) Device Description The XACT Robotic System is a user-controlled positioning system intended to assist in the planning and… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201586 | XACT Robotic System | 2020 | 2 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K201586 (Xact Robotics, Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K131433.
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. 2019, 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 XACT Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous procedures. The system is used for trajectory planning and is intended to assist the physician in positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191332: XACT Robotic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191332
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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