510(k) · Cleared
ClearedSURGIVISIO Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecential Robotics · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 15, 2022 as substantially equivalent to K202547 (Surgivisio, 2021) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1997. 7 later devices descend from it.
- Decided
- Apr 15, 2022
- Review
- 14 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K973598 (1997). 7 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK022337 3D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK042793 Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 2004 · Recalled
- 2 generations backK202547 Surgivisio systemSurgivisio · 2021
- 1 generation backK220627 SURGIVISIO DeviceEcential Robotics · 2022
- This deviceK220946 SURGIVISIO DeviceEcential Robotics · 2022
- Descendant · cites it directly · 6 of its ownK231886 SURGIVISIO DeviceEcential Robotics · 2023
- Descendant · 2 generations on · 3 of its ownK242890 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 3 generations on · 2 of its ownK242933 SPINEART Navigation Instrument SystemSpineart SA · 2025
- Descendant · 2 generations on · 2 of its ownK233228 Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · Recalled
- Descendant · 3 generations on · 1 of its ownK261113 Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231886SURGIVISIO DeviceEcential Robotics · 2023 · cites it directly6descendants
- K242890SPINEART Navigation Instrument SystemSpineart SA · 2025 · 2 generations on3descendants
- K242933SPINEART Navigation Instrument SystemSpineart SA · 2025 · 3 generations on2descendants
- K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics · 2024 · 2 generations on2descendants
- K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K022337 | 3D Navigation Interface for Siremobile Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K042793 | Arcadis Ordic (Available with Options 3D and 3D Navigation Interface) | Siemens Medi Cal Solutions, Inc. | 2004 | 2 |
| −2 | K202547 | Surgivisio system | Surgivisio | 2021 | — |
| −1 | K220627 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| 0 (this device) | K220946 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| +1 | K231886 | SURGIVISIO Device | Ecential Robotics | 2023 | — |
| +2 | K242890 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +3 | K242933 | SPINEART Navigation Instrument System | Spineart SA | 2025 | — |
| +2 | K233228 | Spine Navigation and Robotic-Assistance Device | Ecential Robotics | 2024 | 1 |
| +3 | K261113 | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K202547 | Surgivisio systemSummary page 5…ed to the predicate device There have been no modifications on indication for use on SURGIVISIO Device since the previously approved submission K202547 & K220627. This submission aims at adding a new Imaging set: 3D Offset Imaging Set SPX1 accessory, which enables to deport imagi… | 2021 |
| * | K220627 | SURGIVISIO DeviceSummary page 5…the predicate device There have been no modifications on indication for use on SURGIVISIO Device since the previously approved submission K202547 & K220627. This submission aims at adding a new Imaging set: 3D Offset Imaging Set SPX1 accessory, which enables to deport imaging zone re… | 2022 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231886 | SURGIVISIO Device | 2023 | 6 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K231886 (Ecential Robotics, 2023) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K202547.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The SURGIVISIO device is intended to be used during surgical procedures in which the physician would benefit from the
visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or
objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during
which the spine, pelvis or articulation structures are visualized.
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/K220946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220946: SURGIVISIO Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220946
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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