# K173377: 3.0T 16ch Breast Coil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Nov 28, 2017 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
Longest line of descent: 3 generations back to K001582 (2000). 3 ancestors in all.
3 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)
- K052585: 3T HD Breast Array, Usa Instruments, Inc. (2005) Summary page 5.

## Most influential descendants
- K182958: 1.5T 16ch Breast Coil (2018), 2 descendants of its own
- K222407: 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil (2022), 1 descendant of its own
- K260947: 0.55T 12Ch Breast Coil (2026), 0 descendants of its own

## Indications for use
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

Source page: https://510kreport.com/device/K173377
Methodology: https://510kreport.com/methodology