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. · QIH Automated Radiological Image Processing Software
Cleared on Sep 10, 2026 as substantially equivalent to K241083 (Surgical Information Sciences, Inc., 2024) after a 104-day review. Its family tree reaches back 8 generations to 2005.
- Decided
- Sep 10, 2026
- Review
- 104 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K050438 (2005). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 7 generations backK162830 SIS SoftwareSurgical Information Sciences, Inc. · 2017
- 6 generations backK183019 SIS Software version 3.3.0Surgical Information Sciences, Inc. · 2019
- 5 generations backK192304 SIS Software Version 3.6.0Surgical Information Sciences, Inc. · 2019
- 4 generations backK210071 SIS System (Version 5.1.0)Surgical Information Sciences, Inc. · 2021
- 3 generations backK223032 SIS System (Version 5.6.0)Surgical Information Sciences, Inc. · 2022
- 2 generations backK230977 SIS SystemSurgical Information Sciences, Inc. · 2023
- 1 generation backK241083 SIS SystemSurgical Information Sciences, Inc. · 2024
- This deviceK261795 Quicktome Software SuiteOmniscient Neurotechnology Pty, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −7 | K162830 | SIS Software | Surgical Information Sciences, Inc. | 2017 | — |
| −6 | K183019 | SIS Software version 3.3.0 | Surgical Information Sciences, Inc. | 2019 | — |
| −5 | K192304 | SIS Software Version 3.6.0 | Surgical Information Sciences, Inc. | 2019 | — |
| −4 | K210071 | SIS System (Version 5.1.0) | Surgical Information Sciences, Inc. | 2021 | — |
| −3 | K223032 | SIS System (Version 5.6.0) | Surgical Information Sciences, Inc. | 2022 | — |
| −2 | K230977 | SIS System | Surgical Information Sciences, Inc. | 2023 | — |
| −1 | K241083 | SIS System | Surgical Information Sciences, Inc. | 2024 | — |
| 0 (this device) | K261795 | Quicktome Software Suite | Omniscient Neurotechnology Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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.
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 21 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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, image fusion, 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…
Read the full statement (202 words)
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, image fusion, 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, automated and manual segmentation object creation, detection, and adjustment, 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. Quicktome can be used in conjunction with other clinical methods as an aid in visualization of deep brain structures, such as the subthalamic nuclei (STN), globus pallidus interna (GPi) and ventralis intermediate nucleus (VIM).
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/K261795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261795: Quicktome Software Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261795
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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