# K120701: M2 Wrist Mri System

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Imaging, Ltd.
- Decided: Feb 7, 2013 after 337 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: 1 generation back to K001773 (2000). 1 ancestor in all.
20 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)
- K001773: Orthone, Oni, Inc. (2000)

## Most influential descendants
- K130692: M2 Wrist 2 Mri System (2014), 19 descendants of its own
- K160185: Wrist 3 (2016), 18 descendants of its own
- 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

## Indications for use
The M2 Wrist MRI System is indicated for use as a magnetic resonance imaging device for producing transverse, sagittal and coronal images of the internal structure of the wrist (in patients with an arm length > 320mm). When interpreted by a trained physician, the resultant MR images provide information that can be useful in determining a diagnosis.

Source page: https://510kreport.com/device/K120701
Methodology: https://510kreport.com/methodology