# K053017: Models HRS-63-8 and HRS-127-8 Shoulder Array Coils

- Pathway: 510(k) (Special)
- Applicant: Invivo Corporation
- Decided: Nov 16, 2005 after 21 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K162001: 1.5T and 3.0T 16 CH GE Shoulder Coils (2016), 2 descendants of its own
- K071311: Neocoil 1.5T 8-Channel Shoulder Array Coil (2007), 2 descendants of its own
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (2023), 1 descendant of its own
- K071611: Neocoil 3.0T 8-Channel Shoulder Array Coil (2007), 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
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K053017
Methodology: https://510kreport.com/methodology