# K050622: HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array Coil

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corporation
- Decided: Apr 8, 2005 after 29 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.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103149: 1.5T 16-Channel Hand-Wrist Coil (2011), 4 descendants of its own
- K072935: Speeder 1.5T Wrist Array Coil (2007), 2 descendants of its own
- K223239: 8ch Wrist Coil (2022), 1 descendant of its own
- K222325: 8ch Wrist Coil (2022), 1 descendant of its own
- K213766: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T (2021), 1 descendant of its own

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the wrist and hand that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K050622
Methodology: https://510kreport.com/methodology