510(k) · Cleared
Recalled · Class II · 2025SuRgical Planner (SRP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Theater, LLC · LLZ System, Image Processing, Radiological
Cleared on Feb 12, 2018 as substantially equivalent to K123023 (Surgical Theater, LLC, 2013) after a 333-day review. Its family tree reaches back 7 generations to 1993. 5 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 2018
- Review
- 333 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 6 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 5 generations backK033849 Simplant SystemMaterialise NV · 2004
- 4 generations backK073468 MimicsMaterialise NV · 2008
- 3 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 2 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 1 generation backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- This deviceK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018
- Descendant · cites it directly · 4 of its ownK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK203486 OtoplanCascination AG · 2021
- Descendant · 3 generations on · 0 of its ownK242120 OtoplanCascination AG · 2025
- Descendant · 3 generations on · 0 of its ownK220300 OtoplanCascination AG · 2022
- Descendant · 2 generations on · 0 of its ownK210344 inVisionOSPrecisionos Technology, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020 · cites it directly4descendants
- K203486OtoplanCascination AG · 2021 · 2 generations on2descendants
- K242120OtoplanCascination AG · 2025 · 3 generations on0descendants
- K220300OtoplanCascination AG · 2022 · 3 generations on0descendants
- K210344inVisionOSPrecisionos Technology, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −6 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −5 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −4 | K073468 | Mimics | Materialise NV | 2008 | — |
| −3 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −2 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −1 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| 0 (this device) | K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018 | — |
| +1 | K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020 | 1 |
| +2 | K203486 | Otoplan | Cascination AG | 2021 | — |
| +3 | K242120 | Otoplan | Cascination AG | 2025 | — |
| +3 | K220300 | Otoplan | Cascination AG | 2022 | — |
| +2 | K210344 | inVisionOS | Precisionos Technology, Inc. | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K123023 | Surgery Rehearsal PlatformSummary page 4…otification to obtain a determination of substantial equivalence for our SuRgical Planner (SRP) software that was formerly known as the Surgery Rehearsal Platform (SRP) (K123023). 510(k) Owner’s Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared. Submitter: Surgica… | 2013 |
| † | K163324 | nordicBrainEx | 2017 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201465 | SuRgical Planner (SRP) BrainStorm | 2020 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2025 | Class II | Z-0319-2026 | Under Investigation by firm | A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer. |
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 3.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K201465 (Surgical Theater, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K123023.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Surgical Theater, LLC SuRgical Planner (SRP) is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
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/K170793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170793: SuRgical Planner (SRP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170793
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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