510(k) · Cleared
ClearedBullsai
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turing Medical Technologies, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 13, 2024 as substantially equivalent to K222359 (Omniscient Neurotechnology Pty Ltd (O8t), 2023) after a 113-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Aug 13, 2024
- Review
- 113 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081512 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K222359 | Quicktome Software SuiteSummary page 4…CFR 892.2050 Class: II Product Code: LLZ Primary Predicate: Quicktome Software Suite, K222359 Indications For Use: Bullsai is composed of a set of modules intended for analysis and processing of medical images and other he… | 2023 |
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 16 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K222359.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Bullsai is composed of a set of modules intended for analysis and processing of medical images and other healthcare data. It includes functions for image manipulation, basic measurements, and planning. Bullsai is indicated for use in image processing, registration, atlas-assisted visualization and segmentation, and target export creation and selection of structural MRI images, where an output can be generated for use by a system capable of reading DICOM…
Read the full statement (123 words)
Bullsai is composed of a set of modules intended for analysis and processing of medical images and other healthcare data. It includes functions for image manipulation, basic measurements, and planning.
Bullsai is indicated for use in image processing, registration, atlas-assisted visualization and segmentation, and target export creation and selection of structural MRI images, where an output can be generated for use by a system capable of reading DICOM image sets.
Bullsai is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts based on diffusion reconstruction methods and for the use of said maps to select and create exports.
Typical users of Bullsai are medical professionals, including but not limited to surgeons, clinicians, and radiologists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241094: Bullsai.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241094
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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