# K073131: Micromri Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Micromri, Inc.
- Decided: Jan 18, 2008 after 73 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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) BC-10 1.5T (Mayo Clinic): named in the summary without a submission number
- (no number) HRW Array Coil (Invivo Corporation): named in the summary without a submission number

## Indications for use
The MicroMRl Wrist Coil is a transmitting and receiving device to be used in conjunction with GE Healthcare and Siemens 1.5T MRI systems to image the wrist. The images acquired using the MicroMRI Wrist Coil along multiple axes (axial, coronal, sagittal, and oblique) are a measure of the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the spatial image are proton density, spin-lattice (Ti) and spin-spin (T2) relaxation times, flow velocity and chemical shift. These wrist MRI images when interpreted by a trained physician can be useful in determining a diagnosis. The MicroMRI Wrist Coil cannot be used with an MRI system that supports the use of only receive coils.

Source page: https://510kreport.com/device/K073131
Methodology: https://510kreport.com/methodology