# K240290: AiMIFY (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Aug 21, 2024 after 202 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922470 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223623: SubtleMR (2.3.x), Subtle Medical, Inc. (2023) Summary page 5.

## Indications for use
AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of enhancing tissue in brain MRI images acquired with a gadolinium-based contrast agent. It is intended to enhance MRI images acquired using standard approved dosage per the contrast agent’s instructions for use.

Source page: https://510kreport.com/device/K240290
Methodology: https://510kreport.com/methodology