# K160185: Wrist 3

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Imaging, Ltd.
- Decided: Mar 1, 2016 after 34 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
Longest line of descent: 3 generations back to K001773 (2000). 3 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130692: M2 Wrist 2 Mri System, Aspect Imaging, Ltd. (2014) Summary page 4.

## Most influential descendants
- K170978: Embrace Neonatal MRI System (2017), 17 descendants of its own
- K192002: Lucy Point-of-Care Magnetic Resonance Imaging Device (2020), 13 descendants of its own
- K201722: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (2020), 10 descendants of its own
- K221923: Swoop Portable MR Imaging System (2022), 8 descendants of its own
- K223247: Swoop Portable MR Imaging System (2022), 7 descendants of its own

## Indications for use
The Wrist 3 MRI System is intended for use as a magnetic resonance imaging device for producing axial, sagittal, coronal, and oblique images of the internal structure of the Wrist and Hand. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K160185
Methodology: https://510kreport.com/methodology