510(k) · Cleared
ClearedANDI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imeka Solutions, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 25, 2023 as substantially equivalent to K203518 (Omniscient Neurotechnology Pty Ltd (O8t), 2021) after a 116-day review. Its family tree reaches back 2 generations to 2008. 2 later devices descend from it.
- Decided
- Jul 25, 2023
- Review
- 116 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081512 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK081512 Stealthviz Advanced Planning Application with Stealthdti PackageMedtronic Navigation, Inc. · 2008
- 1 generation backK203518 QuicktomeOmniscient Neurotechnology Pty Ltd (O8t) · 2021
- This deviceK230913 ANDIImeka Solutions, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK252298 ANDI 2.0Imeka Solutions, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261405 ANDI 2.2Imeka Solutions, Inc. · 2026
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 |
|---|---|---|---|---|---|
| −2 | K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc. | 2008 | — |
| −1 | K203518 | Quicktome | Omniscient Neurotechnology Pty Ltd (O8t) | 2021 | — |
| 0 (this device) | K230913 | ANDI | Imeka Solutions, Inc. | 2023 | — |
| +1 | K252298 | ANDI 2.0 | Imeka Solutions, Inc. | 2025 | — |
| +2 | K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203518 | QuicktomeSummary page 4…re Archiving and Communications System (21 CFR § 892.2050) Classification Product Code: QIH, LLZ Predicate Device: Quicktome (K203518) Description of Device ANDI is quantitative imaging software that extracts features from medical images to provide adjunctive i… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252298 | ANDI 2.0 | 2025 | 1 |
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 15 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252298 (Imeka Solutions, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K203518.
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. 2023, 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?
ANDI is intended for display of medical images and other healthcare data. It includes functions for image review, basic measurements, planning, and visualization (MPR reconstructions). Modules are available for image processing and atlas-assisted visualization and segmentation, where an output can be generated for use by a system capable of reading DICOM image sets. ANDI is indicated for use in the processing of diffusion-weighted MRI sequences into 3D…
Read the full statement (171 words)
ANDI is intended for display of medical images and other healthcare data. It includes functions for image review, basic measurements, planning, and visualization (MPR reconstructions). Modules are available for image processing and atlas-assisted visualization and segmentation, where an output can be generated for use by a system capable of reading DICOM image sets.
ANDI is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts. The information presented by ANDI is for measurement of brain white matter tracts only without making a prediction, diagnosis, or interpretation of brain health. It is the responsibility of the physician to review all clinical information associated with a patient in order to make a diagnosis and to determine next steps in the clinical care of the patient.
Typical users of ANDI are medical professionals, including but not limited to neurologists and radiologists. ANDI should be used only as adjunctive information. The decision made by trained medical professionals will be considered final. It is not a diagnostic aid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230913: ANDI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230913
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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