510(k) · Cleared
ClearedANDI 2.2
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 May 28, 2026 as substantially equivalent to K252298 (Imeka Solutions, Inc., 2025) after a 29-day review. Its family tree reaches back 4 generations to 2008.
- Decided
- May 28, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K081512 (2008). No later device cites it as a predicate yet.
- Root · 4 generations backK081512 Stealthviz Advanced Planning Application with Stealthdti PackageMedtronic Navigation, Inc. · 2008
- 3 generations backK203518 QuicktomeOmniscient Neurotechnology Pty Ltd (O8t) · 2021
- 2 generations backK230913 ANDIImeka Solutions, Inc. · 2023
- 1 generation backK252298 ANDI 2.0Imeka Solutions, Inc. · 2025
- This deviceK261405 ANDI 2.2Imeka Solutions, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K081512 | Stealthviz Advanced Planning Application with Stealthdti Package | Medtronic Navigation, Inc. | 2008 | — |
| −3 | K203518 | Quicktome | Omniscient Neurotechnology Pty Ltd (O8t) | 2021 | — |
| −2 | K230913 | ANDI | Imeka Solutions, Inc. | 2023 | — |
| −1 | K252298 | ANDI 2.0 | Imeka Solutions, Inc. | 2025 | — |
| 0 (this device) | K261405 | ANDI 2.2 | Imeka Solutions, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K252298 | ANDI 2.0Summary page 5…ation Name: Medical image management and processing system (21 CFR § 892.2050) Classification Product Code: QIH, LLZ Predicate Device: ANDI 2.0 (K252298) Description of Device ANDI is software as a medical device (SaMD) that can be deployed on a cloud-based system or installed on… | 2025 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 4 ancestors has a recall.
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?
ANDI is intended for the display of medical images and other healthcare data. It includes functions for processing MR images, atlas-assisted visualization, segmentation, and volumetric quantification of segmentable brain structures. The output is generated for use by a system capable of reading DICOM image sets. The information presented by ANDI does not provide prediction, diagnosis, or interpretation of brain health. Clinical interpretation and…
Read the full statement (133 words)
ANDI is intended for the display of medical images and other healthcare data. It includes functions for processing MR images, atlas-assisted visualization, segmentation, and volumetric quantification of segmentable brain structures. The output is generated for use by a system capable of reading DICOM image sets.
The information presented by ANDI does not provide prediction, diagnosis, or interpretation of brain health. Clinical interpretation and decision-making are the responsibility of the physician, who must review all clinical information associated with a patient in order to make a diagnosis and to determine the 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261405: ANDI 2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261405
Report an extraction error
Are you the manufacturer?
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