# K103149: 1.5T 16-Channel Hand-Wrist Coil

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Jan 3, 2011 after 70 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050622 (2005). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050622: HRW-63-8 Wrist Array Coil; HRW-127-8 Wrist Array Coil, Mri Devices Corporation (2005) Summary page 1.

## Most influential descendants
- 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
- K162623: 16ch T/R Hand Wrist Coil (2016), 1 descendant of its own
- K262294: dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T (2026), 0 descendants of its own
- K173469: 16ch T/R Hand Wrist Coil (2018), 0 descendants of its own

## Recalls of this device
- Sep 14, 2020 · Class III · Z-0126-2021: The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

## Indications for use
The coil is indicated for use on the order of a physician, in conjunction with GE 1.5T MR scanners as an accessory to produce images of the wrist and hand regions, as an aid to diagnosis.

Source page: https://510kreport.com/device/K103149
Methodology: https://510kreport.com/methodology