# K201141: FIRMM

- Pathway: 510(k) (Traditional)
- Applicant: Nous Imaging, Inc.
- Decided: Aug 26, 2020 after 119 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KinetiCor Motion Correction System: named in the summary without a submission number

## Indications for use
The Nous FIRMM system is an accessory to an MRI scanner to calculate and display patient motion during a head scan. The motion results are derived from the MR image data as it is being acquired. MR images can be imported during the scan, and analyzed to detect patient motion in real-time. FIRMM enables the operator to become aware of patient motion during the scanning session and can be used to support scanning efficiency. The device is intended for prescription use only.

Source page: https://510kreport.com/device/K201141
Methodology: https://510kreport.com/methodology