510(k) · Cleared
ClearedQuicktome Software Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omniscient Neurotechnology Pty Ltd (O8t) · LLZ System, Image Processing, Radiological
Cleared on May 30, 2023 as substantially equivalent to K081512 (Medtronic Navigation, Inc., 2008) after a 299-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- May 30, 2023
- Review
- 299 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081512 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK081512 Stealthviz Advanced Planning Application with Stealthdti PackageMedtronic Navigation, Inc. · 2008
- This deviceK222359 Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (O8t) · 2023
- Descendant · cites it directly · 0 of its ownK251009 Cirrus Resting State fMRI SoftwareSora Neuroscience, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241094 BullsaiTuring Medical Technologies, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc. | 2008 | — |
| 0 (this device) | K222359 | Quicktome Software Suite | Omniscient Neurotechnology Pty Ltd (O8t) | 2023 | — |
| +1 | K251009 | Cirrus Resting State fMRI Software | Sora Neuroscience, Inc. | 2025 | — |
| +1 | K241094 | Bullsai | Turing Medical Technologies, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081512 | Stealthviz Advanced Planning Application with Stealthdti PackageSummary page 4…892.2050) Regulatory Class: Class II Product Code: LLZ 5.3 Predicate Device StealthViz Advanced Planning Application with StealthDTI Package, K081512 This Predicate has not been subject to a design-related recall. Reference Devices: Quicktome, K203518; Brainlab iPlan Cranial, K1… | 2008 |
| † | K203518 | Quicktome | 2021 |
| † | K113732 | Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine) | 2012 |
What descends from it? (2)
2 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?
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 Quicktome Software Suite is composed of a set of modules intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation…
Read the full statement (158 words)
The Quicktome Software Suite is composed of a set of modules intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies.
Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets.
Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds.
Typical users of Quicktome 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/K222359 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222359: Quicktome Software Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222359
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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