510(k) · Cleared
ClearedAibolit 3D+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aibolit Technologies, LLC · LLZ System, Image Processing, Radiological
Cleared on Jan 12, 2023 as substantially equivalent to K211443 (Aibolit Technologies, LLC, 2022) and 1 other predicate after a 150-day review. Its family tree reaches back 11 generations to 1993.
- Decided
- Jan 12, 2023
- Review
- 150 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K924630 (1993). 13 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 7 generations between
- 3 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 2 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 1 generation backK211443 Aibolit 3D+Aibolit Technologies, LLC · 2022
- This deviceK222458 Aibolit 3D+Aibolit Technologies, LLC · 2023
Show all 11 generations
- Root · 11 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 10 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 9 generations backK033849 Simplant SystemMaterialise NV · 2004
- 8 generations backK073468 MimicsMaterialise NV · 2008
- 7 generations backK093269 Procedure Rehearsal StudioSimbionix, Ltd. · 2010
- 6 generations backK112387 Procedure Rehearsal Studio (TM)Simbionix, Ltd. · 2011
- 5 generations backK123023 Surgery Rehearsal PlatformSurgical Theater, LLC · 2013
- 4 generations backK142107 Echo True 3D ViewerEchopixel, Inc. · 2015 · Recalled
- 3 generations backK171356 Clarity RevealCeevra, Inc. · 2017
- 2 generations backK173274 Ceevra Reveal 2.0Ceevra, Inc. · 2018
- 1 generation backK211443 Aibolit 3D+Aibolit Technologies, LLC · 2022
- This deviceK222458 Aibolit 3D+Aibolit Technologies, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −10 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −9 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −8 | K073468 | Mimics | Materialise NV | 2008 | — |
| −7 | K093269 | Procedure Rehearsal Studio | Simbionix, Ltd. | 2010 | — |
| −6 | K112387 | Procedure Rehearsal Studio (TM) | Simbionix, Ltd. | 2011 | — |
| −5 | K123023 | Surgery Rehearsal Platform | Surgical Theater, LLC | 2013 | — |
| −4 | K142107 | Echo True 3D Viewer | Echopixel, Inc. | 2015 | 1 |
| −3 | K171356 | Clarity Reveal | Ceevra, Inc. | 2017 | — |
| −2 | K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018 | — |
| −1 | K211443 | Aibolit 3D+ | Aibolit Technologies, LLC | 2022 | — |
| 0 (this device) | K222458 | Aibolit 3D+ | Aibolit Technologies, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K211443 | Aibolit 3D+Summary page 4…LZ Regulation: 21 CFR 892.2050 Predicate Devices: Primary Predicate Aibolit Technologies, LLC 3D+ System [510(k) K211443]. Reference Predicate Ceevra, Inc. Ceevra Reveal 2.0 Image Pr… | 2022 |
| * | K173274 | Ceevra Reveal 2.0Summary page 4…ference Predicate Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System [510(k) K173274] 1 Indications for Use: Aibolit 3D+… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 1 other device also cites its predicate K211443.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who 1s responsible for making all final patient management decisions.
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/K222458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222458: Aibolit 3D+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222458
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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