510(k) · Cleared
Clearedicobrain aria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icometrix NV · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on Nov 7, 2024 as substantially equivalent to DEN180005 (Imagen Technologies, Inc., 2018) after a 237-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Nov 7, 2024
- Review
- 237 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- This deviceK240712 icobrain ariaIcometrix NV · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| 0 (this device) | K240712 | icobrain aria | Icometrix NV | 2024 | — |
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 QBS? 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 QBS device
- #1 K260378 Rayvolvescore 15.2 · 4 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 |
|---|---|---|---|
| * | DEN180005 | OsteoDetectSummary page 5…lassification Panel: Radiology 3 Predicate Device Device OsteoDetect De Novo Number DEN180005 Manufacturer Imagen Technologies Regulation Number 21 CFR 892.2090 Reg… | 2018 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN180005.
How does its category compare?
All QBS devicesQBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QBS
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBS
123in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBS
No recall names QBS since 2007.
Adverse event reports per year · QBS
No MAUDE report names QBS since 2007.
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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 123 | 0 | — |
What is it indicated for?
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADXx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin…
Read the full statement (236 words)
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADXx) software device to be used as a concurrent reading aid to help trained radiologists in the detection, assessment and characterization of Amyloid Related Imaging Abnormalities (ARIA) from a set of brain MR images. The software provides information about the presence, location, size, severity and changes of ARIA-E (brain edema or sulcal effusions) and ARIA-H (hemosiderin deposition, including microhemorrhage and superficial siderosis). Patient management decisions should not be made solely on the basis of analysis by icobrain aria.
The intended users of icobrain aria are trained radiologists. When a radiologist assesses the original MR images, both the icobrain aria annotated images and the original, unaltered images are used for concurrent reading.
icobrain aria is intended to be used in the population of patients with Alzheimer's disease receiving treatment with an amyloid beta-directed antibody using the same ARIA radiographic severity scale as described in Aduhelm®/Leqembi® prescription information, and presenting for safety monitoring, including severity assessment and monitoring changes of ARIA.
icobrain aria is an adjunct tool and is not intended to replace a radiologist's review of the images or his or her clinical judgment. icobrain aria is not intended as an independent interpretation of MR images. Decisions should not be made solely based on analysis by icobrain aria.
The device is not intended to be used to segment macrohemorrhages (hemorrhages with a diameter of 10 mm or more).
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/K240712 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240712: icobrain aria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240712
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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