510(k) · Cleared
ClearedIsys 1 (U.S),Accessory, Non-Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isys Medizintechnik GmbH · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 11, 2014 as substantially equivalent to K974513 (Philips Medical Systems (Cleveland), Inc., 1998) after a 298-day review. Its family tree reaches back 1 generation to 1998. 6 later devices descend from it.
- Decided
- Mar 11, 2014
- Review
- 298 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974513 (1998). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974513 PinpointPhilips Medical Systems (Cleveland), Inc. · 1998
- This deviceK131433 Isys 1 (U.S),Accessory, Non-SterileIsys Medizintechnik GmbH · 2014
- Descendant · cites it directly · 3 of its ownK191332 XACT Robotic SystemXact Robotics, Ltd. · 2019
- Descendant · 2 generations on · 2 of its ownK201586 XACT Robotic SystemXact Robotics, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK203720 MicromateIsys Medizintechnik GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK230130 Micromate™ Navi+Isys Medizintechnik GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK213759 XACT Robotic System, ACE ModelXact Robotics, Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K191332XACT Robotic SystemXact Robotics, Ltd. · 2019 · cites it directly3descendants
- K201586XACT Robotic SystemXact Robotics, Ltd. · 2020 · 2 generations on2descendants
- K203720MicromateIsys Medizintechnik GmbH · 2021 · cites it directly1descendant
- K230130Micromate™ Navi+Isys Medizintechnik GmbH · 2023 · 2 generations on0descendants
- K213759XACT Robotic System, ACE ModelXact Robotics, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974513 | Pinpoint | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
| 0 (this device) | K131433 | Isys 1 (U.S),Accessory, Non-Sterile | Isys Medizintechnik GmbH | 2014 | — |
| +1 | K191332 | XACT Robotic System | Xact Robotics, Ltd. | 2019 | — |
| +2 | K201586 | XACT Robotic System | Xact Robotics, Ltd. | 2020 | — |
| +1 | K203720 | Micromate | Isys Medizintechnik GmbH | 2021 | — |
| +2 | K230130 | Micromate™ Navi+ | Isys Medizintechnik GmbH | 2023 | — |
| +3 | K213759 | XACT Robotic System, ACE Model | Xact Robotics, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K974513 | PinpointSummary page 8…= Page 8 === Section 510k Summary /5 S 005 510(k) Number: K131433 L Device Comparison Summary: Reference PinPoint iSYS 1 .(fo[' new Equivalence submission) ? 510k-Number K974513 K131433 Manufacturer PHILIPS MEDICAL iSYS Medizintechnik SYSTEMS GmbH (CLEVELAND), INC. Bergwerksweg 21 595 Miner rd. A-6370 Kitz… | 1998 |
| † | K955268 | PQ-2000+ Computed Tomography X-Ray System | 1996 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2014, 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 iSYS | device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the surgeon in the positioning of a needle or electrode where both computed tomography (CT) and fluoroscopic imaging can be used for target trajectory planning and intraoperative tracking. The needle or electrode is then manually advanced by the surgeon, Trajectory planning is made with software that is not part of the iSYS device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131433: Isys 1 (U.S),Accessory, Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131433
Report an extraction error
Are you the manufacturer?
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