510(k) · Cleared
ClearedKOALA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ib Lab GmbH · LLZ System, Image Processing, Radiological
Cleared on Nov 5, 2019 as substantially equivalent to K172327 (Ortho Kinematics, Inc., 2017) after a 92-day review. Its family tree reaches back 7 generations to 1995. 6 later devices descend from it.
- Decided
- Nov 5, 2019
- Review
- 92 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942948 (1995). 10 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK942948 Stryker Powered StretcherStryker Corp. · 1995
- 6 generations backK022309 Stryker Powered Wheeled StretcherStryker Corp. · 2002 · Recalled
- 5 generations backK090136 Steris Cmax XLT Surgical TableSTERIS Corporation · 2009 · Recalled
- 4 generations backK112109 The Kinegraph Vma Software, the Motion Normalizer Patient Handling…Ortho Kinematics, Inc. · 2011
- 3 generations backK130743 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0…Ortho Kinematics, Inc. · 2013
- 2 generations backK133875 The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2…Ortho Kinematics, Inc. · 2014 · Recalled
- 1 generation backK172327 VMA™ System version 3.0Ortho Kinematics, Inc. · 2017
- This deviceK192109 KOALAIb Lab GmbH · 2019
- Descendant · cites it directly · 2 of its ownK203696 RBkneeRadiobotics Aps · 2021
- Descendant · cites it directly · 1 of its ownK223621 DeepXrayAlpha Intelligence Manifolds, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK223646 IB Lab LAMAIb Lab GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK253172 MediAI-OACrescom Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK241593 BoneMetrics (US)Gleamer Sas · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K203696RBkneeRadiobotics Aps · 2021 · cites it directly2descendants
- K223621DeepXrayAlpha Intelligence Manifolds, Inc. · 2023 · cites it directly1descendant
- K223646IB Lab LAMAIb Lab GmbH · 2023 · cites it directly1descendant
- K253172MediAI-OACrescom Co., Ltd. · 2026 · 2 generations on0descendants
- K241593BoneMetrics (US)Gleamer Sas · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942948 | Stryker Powered Stretcher | Stryker Corp. | 1995 | — |
| −6 | K022309 | Stryker Powered Wheeled Stretcher | Stryker Corp. | 2002 | 6 |
| −5 | K090136 | Steris Cmax XLT Surgical Table | STERIS Corporation | 2009 | 4 |
| −4 | K112109 | The Kinegraph Vma Software, the Motion Normalizer Patient Handling and Data… | Ortho Kinematics, Inc. | 2011 | — |
| −3 | K130743 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.0; the Motion… | Ortho Kinematics, Inc. | 2013 | — |
| −2 | K133875 | The Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion… | Ortho Kinematics, Inc. | 2014 | 4 |
| −1 | K172327 | VMA™ System version 3.0 | Ortho Kinematics, Inc. | 2017 | — |
| 0 (this device) | K192109 | KOALA | Ib Lab GmbH | 2019 | — |
| +1 | K203696 | RBknee | Radiobotics Aps | 2021 | — |
| +1 | K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | 2023 | — |
| +1 | K223646 | IB Lab LAMA | Ib Lab GmbH | 2023 | — |
| +2 | K253172 | MediAI-OA | Crescom Co., Ltd. | 2026 | — |
| +2 | K241593 | BoneMetrics (US) | Gleamer Sas | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K172327 | VMA™ System version 3.0Summary page 4…tions system (21 C.F.R. 892.2050) Regulatory Class: Class II Product Code: LLZ/892.2050, JAK/892.1750 Predicate Device: Ortho Kinematics, Inc.’s VMA System version 3.0 (K172327) TM Reference Device: Zebra Medical Vision Ltd.’s HealthCCS (K172983) Dev… | 2017 |
| † | K172983 | HealthCCS | 2018 |
What descends from it? (6)
4 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)
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 24 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K203696 (Radiobotics Aps, 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. 2019, 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?
IB Lab KOALA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of…
Read the full statement (115 words)
IB Lab KOALA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192109: KOALA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192109
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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