510(k) · Cleared
ClearedSurgivisio system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgivisio · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 26, 2021 as substantially equivalent to K042793 (Siemens Medi Cal Solutions, Inc., 2004) after a 205-day review. Its family tree reaches back 3 generations to 1997. 9 later devices descend from it.
- Decided
- Mar 26, 2021
- Review
- 205 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K973598 (1997). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK022337 3D Navigation Interface for Siremobile Iso-C 3DSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK042793 Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Siemens Medi Cal Solutions, Inc. · 2004 · Recalled
- This deviceK202547 Surgivisio systemSurgivisio · 2021
- Descendant · cites it directly · 8 of its ownK220627 SURGIVISIO DeviceEcential Robotics · 2022
- Descendant · cites it directly · 7 of its ownK220946 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
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K220627SURGIVISIO DeviceEcential Robotics · 2022 · cites it directly8descendants
- K220946SURGIVISIO DeviceEcential Robotics · 2022 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −2 | K022337 | 3D Navigation Interface for Siremobile Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K042793 | Arcadis Ordic (Available with Options 3D and 3D Navigation Interface) | Siemens Medi Cal Solutions, Inc. | 2004 | 2 |
| 0 (this device) | K202547 | Surgivisio system | Surgivisio | 2021 | — |
| +1 | K220627 | SURGIVISIO Device | Ecential Robotics | 2022 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2022 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K042793 | Arcadis Ordic (Available with Options 3D and 3D Navigation Interface)Summary page 4…intensified fluoroscopic x-ray system Regulatory class: II Primary product code: OWB Legally marketed device K042793 - Arcadis Orbic (available with options 3D and 3D to which equivalence is navigation interface) - Manufacturer:… | 2004 |
What descends from it? (9)
3 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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K220627 (Ecential Robotics, 2022) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K042793.
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. 2021, 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 medical 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/K202547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202547: Surgivisio system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202547
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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