# K162001: 1.5T and 3.0T 16 CH GE Shoulder Coils

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Aug 31, 2016 after 42 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 K053017 (2005). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053017: Models HRS-63-8 and HRS-127-8 Shoulder Array Coils, Invivo Corporation (2005) Summary page 8.

## Most influential descendants
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (2023), 1 descendant of its own
- K260519: Smart Fit TorsoCardiac 1.5T (2026), 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 16 Channel Shoulder Coil is to be used in conjunction with Magnetic Resonance Scanners to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K162001
Methodology: https://510kreport.com/methodology