# K240712: icobrain aria

- Pathway: 510(k) (Traditional)
- Applicant: Icometrix NV
- Decided: Nov 7, 2024 after 237 days
- Product code: QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180005 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180005: OsteoDetect, Imagen Technologies, Inc. (2018) Summary page 5.

## Indications for use
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).

Source page: https://510kreport.com/device/K240712
Methodology: https://510kreport.com/methodology