510(k) · Cleared
Recalled · Class II · 2025SuRgical Planner (SRP) BrainStorm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Theater, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 17, 2020 as substantially equivalent to K170793 (Surgical Theater, LLC, 2018) after a 45-day review. Its family tree reaches back 8 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Jul 17, 2020
- Review
- 45 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K924630 (1993). 10 ancestors in all, the oldest K924810 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 6 generations backK033849 Simplant SystemMaterialise NV · 2004
- 5 generations backK073468 MimicsMaterialise NV · 2008
- 4 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 3 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 2 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 1 generation backK170793 SuRgical Planner (SRP)Surgical Theater, LLC · 2018 · Recalled
- This deviceK201465 SuRgical Planner (SRP) BrainStormSurgical Theater, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK203486 OtoplanCascination AG · 2021
- Descendant · 2 generations on · 0 of its ownK242120 OtoplanCascination AG · 2025
- Descendant · 2 generations on · 0 of its ownK220300 OtoplanCascination AG · 2022
- Descendant · cites it directly · 0 of its ownK210344 inVisionOSPrecisionos Technology, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −7 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −6 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −5 | K073468 | Mimics | Materialise NV | 2008 | — |
| −4 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −3 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −2 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −1 | K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | 2018 | 1 |
| 0 (this device) | K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | 2020 | — |
| +1 | K203486 | Otoplan | Cascination AG | 2021 | — |
| +2 | K242120 | Otoplan | Cascination AG | 2025 | — |
| +2 | K220300 | Otoplan | Cascination AG | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 21.6 · 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 |
|---|---|---|---|
| * | K170793 | SuRgical Planner (SRP)Summary page 4…LLZ • Regulatory Classification: II • Device Panel: Radiology Predicate Device SuRgical Planner (SRP), 510(k) Number: K170793 Volume 5 510(k) Summary Page 5-1 Special 510(… | 2018 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2025 | Class II | Z-0325-2026 | 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 27 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K203486 (Cascination AG, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Planner (SRP) BrainStorm 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/K201465 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201465: SuRgical Planner (SRP) BrainStorm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201465
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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