# K241121: Micsi-RMT

- Pathway: 510(k) (Traditional)
- Applicant: Microstructure Imaging, Inc.
- Decided: Jul 17, 2024 after 85 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: 5 generations back to K922470 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191688: SubtleMR, Subtle Medical, Inc. (2019) Summary page 4.

## Indications for use
MICSI-RMT is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head MRI.

Source page: https://510kreport.com/device/K241121
Methodology: https://510kreport.com/methodology