510(k) · Cleared
ClearedKBA3D (v2.4.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S.M.A.I.O · LLZ System, Image Processing, Radiological
Cleared on Aug 17, 2026 as substantially equivalent to K223841 (S.M.A.I.O, 2023) and 1 other predicate after a 103-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Aug 17, 2026
- Review
- 103 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K896095 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 10 generations between
- 3 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 2 generations backK213975 KEOPS Balance Analyzer 3DS.M.A.I.O · 2022
- 1 generation backK223841 KBA3DS.M.A.I.O · 2023
- This deviceK261500 KBA3D (v2.4.0)S.M.A.I.O · 2026
Show all 14 generations
- Root · 14 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 13 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 12 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 11 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 10 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 9 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 8 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 7 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 6 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 5 generations backK141669 SurgimapNemaris, Inc. · 2014
- 4 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 3 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 2 generations backK213975 KEOPS Balance Analyzer 3DS.M.A.I.O · 2022
- 1 generation backK223841 KBA3DS.M.A.I.O · 2023
- This deviceK261500 KBA3D (v2.4.0)S.M.A.I.O · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −13 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −12 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −11 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −10 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −9 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −8 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −7 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −6 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −5 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| −4 | K170172 | UNiD Spine Analyzer | Medicrea International | 2017 | — |
| −3 | K180091 | UNiD Spine Analyzer | Medicrea International | 2018 | — |
| −2 | K213975 | KEOPS Balance Analyzer 3D | S.M.A.I.O | 2022 | — |
| −1 | K223841 | KBA3D | S.M.A.I.O | 2023 | — |
| 0 (this device) | K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K223841 | KBA3DSummary page 5…R 892.2050 Classification Codes: LLZ Classification Panel: Radiology Devices C1. PRIMARY PREDICATE DEVICE K223841 KEOPS Balance Analyzer 3D (KBA3D v2.0.0) C2. ADDITIONAL PREDICATE DEVICE K213975… | 2023 |
| * | K213975 | KEOPS Balance Analyzer 3DSummary page 5…C1. PRIMARY PREDICATE DEVICE K223841 KEOPS Balance Analyzer 3D (KBA3D v2.0.0) C2. ADDITIONAL PREDICATE DEVICE K213975 KEOPS Balance Analyzer 3D (KBA3D) Page 2 of 9 D. DEVICE DESCRIPTION The subje… | 2022 |
| † | K211981 | KHEIRON® Spinal Fixation System | 2022 |
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 36 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 27 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 KBA3D v2.4.0 is intended for assisting healthcare professionals in viewing X-ray images, identifying spinal anatomical structures, simulating surgical correction strategies, and defining the geometry of patient-specific implants (such as rods) based on the surgeon's validated surgical plan.
The device allows users to:
* Manually identify anatomical structure on X-ray images
» Perform spine-related measurements
» Manually simulate surgical correction procedures
* Design customized implant geometry
Clinical judgment and experience are required to properly use the software.
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/K261500 · printed Nov 5, 2026
Cite this page
510(k) Report. “K261500: KBA3D (v2.4.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K261500
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026