510(k) · Cleared
ClearedKBA3D
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 May 30, 2023 as substantially equivalent to K213975 (S.M.A.I.O, 2022) and 2 other predicates after a 159-day review. Its family tree reaches back 13 generations to 1990. 1 later device descends from it.
- Decided
- May 30, 2023
- Review
- 159 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K896095 (1990). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations between
- 3 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 2 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 1 generation backK213975 KEOPS Balance Analyzer 3DS.M.A.I.O · 2022
- This deviceK223841 KBA3DS.M.A.I.O · 2023
- Descendant · cites it directly · 0 of its ownK261500 KBA3D (v2.4.0)S.M.A.I.O · 2026
Show all 13 generations
- Root · 13 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 12 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 11 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 10 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 9 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 8 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 7 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 6 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 5 generations backK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- 4 generations backK141669 SurgimapNemaris, Inc. · 2014
- 3 generations backK170172 UNiD Spine AnalyzerMedicrea International · 2017
- 2 generations backK180091 UNiD Spine AnalyzerMedicrea International · 2018
- 1 generation backK213975 KEOPS Balance Analyzer 3DS.M.A.I.O · 2022
- This deviceK223841 KBA3DS.M.A.I.O · 2023
Most influential descendants
Showing 1 of 1 · See all- K261500KBA3D (v2.4.0)S.M.A.I.O · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −12 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −11 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −10 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −9 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −8 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −7 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −6 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −5 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| −4 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| −3 | K170172 | UNiD Spine Analyzer | Medicrea International | 2017 | — |
| −2 | K180091 | UNiD Spine Analyzer | Medicrea International | 2018 | — |
| −1 | K213975 | KEOPS Balance Analyzer 3D | S.M.A.I.O | 2022 | — |
| 0 (this device) | K223841 | KBA3D | S.M.A.I.O | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K213975 | KEOPS Balance Analyzer 3DSummary page 4…LLZ Classification Panel: Radiology Devices Regulation Number: 21 CFR sections 892.2050 C1. PRIMARY PREDICATE DEVICE K213975 KEOPS Balance Analyzer 3D (KBA3D) C2. PREDICATE DEVICES K180091… | 2022 |
| * | K180091 | UNiD Spine AnalyzerSummary page 4…21 CFR sections 892.2050 C1. PRIMARY PREDICATE DEVICE K213975 KEOPS Balance Analyzer 3D (KBA3D) C2. PREDICATE DEVICES K180091 UNiD Spine Analyzer, Medicrea International K141669 Nemar… | 2018 |
| * | K141669 | SurgimapSummary page 4…KEOPS Balance Analyzer 3D (KBA3D) C2. PREDICATE DEVICES K180091 UNiD Spine Analyzer, Medicrea International K141669 Nemaris Surgimap 2.0 C3. REFERENCE DEVICE K210574 NuVasiv… | 2014 |
| † | K210574 | NuVasive Pulse System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261500 | KBA3D (v2.4.0) | 2026 | 0 |
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 33 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 26 ancestors have a recall of any class.
- Of its descendants, K261500 (S.M.A.I.O, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K213975.
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?
The KBA3D v2.0.0 is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.…
Read the full statement (105 words)
The KBA3D v2.0.0 is intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries. The device allows surgeons and service providers to perform spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for design and placement of surgical implants. Clinical judgment and experience are required to properly use the software.
The patient population targeted with the use of the KBA3D v2.0.0 software includes patients with mature skeletons requiring imaging measurements and planning of surgical procedures. The Bendini Rod Bending algorithm is intended for patients older than 22 years old.
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/K223841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223841: KBA3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223841
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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