510(k) · Cleared
ClearedIntraOp VSP Software Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xironetic, LLC · LLZ System, Image Processing, Radiological
Cleared on Oct 21, 2022 as substantially equivalent to K172418 (Novarad Corporation, 2018) after a 389-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- Oct 21, 2022
- Review
- 389 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K924630 (1993). 50 ancestors in all, the oldest K890348 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations between
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- 1 generation backK172418 OpenSightNovarad Corporation · 2018
- This deviceK213128 IntraOp VSP Software DeviceXironetic, LLC · 2022
- Descendant · cites it directly · 0 of its ownK232189 OrionXRHoth Intelligence, Inc. · 2023
Show all 10 generations
- Root · 10 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 9 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 8 generations backK033849 Simplant SystemMaterialise NV · 2004
- 7 generations backK073468 MimicsMaterialise NV · 2008
- 6 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 5 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 4 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 3 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 2 generations backK170167 True 3D Viewer SoftwareEchopixel, Inc. · 2017 · Recalled
- 1 generation backK172418 OpenSightNovarad Corporation · 2018
- This deviceK213128 IntraOp VSP Software DeviceXironetic, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K232189OrionXRHoth Intelligence, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −9 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −8 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −7 | K073468 | Mimics | Materialise NV | 2008 | — |
| −6 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −5 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −4 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −3 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −2 | K170167 | True 3D Viewer Software | Echopixel, Inc. | 2017 | 1 |
| −1 | K172418 | OpenSight | Novarad Corporation | 2018 | — |
| 0 (this device) | K213128 | IntraOp VSP Software Device | Xironetic, LLC | 2022 | — |
| +1 | K232189 | OrionXR | Hoth Intelligence, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2017 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K172418 | OpenSightSummary page 5…K213128 SUBSTANTIAL EQUIVALENCE: The proposed software device, IntraOpVSP, is substantially equivalent to the predicate device, OpenSight (K172418). The intended use of both the proposed device and predicate device is for visualizing 3D patient data using augmented reality fo… | 2018 |
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 |
|---|---|---|---|
| K232189 | OrionXR | 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 29 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 21 of the 50 ancestors have a recall of any class.
- Of its descendants, K232189 (Hoth Intelligence, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K172418.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
IntraOpVSP is a software device that is indicated for use with an augmented reality head-mounted display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy. IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient’s anatomical targets for use in preoperative planning and heads-up 3D visualization during…
Read the full statement (119 words)
IntraOpVSP is a software device that is indicated for use with an augmented reality head-mounted display which allows for visualization and orientation of 3D digital models of selected structures of a patient's anatomy.
IntraOpVSP is intended to supplement conventional Virtual Surgical Planning (VSP) by facilitating perception of the shape and scale of a patient’s anatomical targets for use in preoperative planning and heads-up 3D visualization during surgery.
IntraOpVSP is not intended to provide diagnosis or to guide surgical instrumentation. It is not to be used for stereotactic procedures or surgical navigation.
IntraOpVSP is intended for use by surgeons who have been trained to operate IntraOpVSP. IntraOpVSP software is designed for use with performance-tested hardware specified in the User Manual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213128: IntraOp VSP Software Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213128
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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