510(k) · Cleared
ClearedProcedure Rehearsal Studio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simbionix, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 20, 2010 as substantially equivalent to K073468 (Materialise NV, 2008) and 1 other predicate after a 305-day review. Its family tree reaches back 4 generations to 1993. 41 later devices descend from it.
- Decided
- Aug 20, 2010
- Review
- 305 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). 41 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK073468 MimicsMaterialise NV · 2008
- This deviceK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- Descendant · cites it directly · 40 of its ownK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- Descendant · 2 generations on · 37 of its ownK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- Descendant · 3 generations on · 27 of its ownK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 18 of its ownK171356 Clarity RevealCeevra, Inc. · 2017
- Descendant · 5 generations on · 17 of its ownK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K112387Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011 · cites it directly40descendants
- K123023Surgery Rehearsal PlatformSurgical Theater, LLC · 2013 · 2 generations on37descendants
- K142107Echo True 3D ViewerEchopixel, Inc. · 2015 · 3 generations on27descendants
- K171356Clarity RevealCeevra, Inc. · 2017 · 4 generations on18descendants
- K173274Ceevra Reveal 2.0Ceevra, Inc. · 2018 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K073468 | Mimics | Materialise NV | 2008 | — |
| 0 (this device) | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| +1 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| +2 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| +3 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| +4 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| +5 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K073468 | MimicsSummary page 1…050 Product Code: LLZ Classification: Class II Review Panel: Radiology Predicate Devices: * Mimics® by Materiallise N.V., K073468. * CardioCT by Shina System Ltd., K070226 Device Description: The Simbioniix PROcedure Rehearsal Studio software allows cli… | 2008 |
| * | K070226 | CardioctSummary page 1…cation: Class II Review Panel: Radiology Predicate Devices: * Mimics® by Materiallise N.V., K073468. * CardioCT by Shina System Ltd., K070226 Device Description: The Simbioniix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anat… | 2007 |
What descends from it? (41)
See all 412 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 17 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K112387 (Simbionix, Ltd., 2011) has gone furthest, with 40 descendants of its own.
- 8 other devices also cite its predicate K073468.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093269: Procedure Rehearsal Studio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093269
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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