# K260947: 0.55T 12Ch Breast Coil

- Pathway: 510(k) (Special)
- Applicant: Neocoil, LLC
- Decided: Apr 23, 2026 after 31 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: 6 generations back to K001582 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Neocoil, LLC (2022) Summary page 5.

## Indications for use
The NeoCoil 12Ch Breast Coil is a Magnetic Resonance Imaging (MRI) RF Receive-Only Coil intended for use by trained medical professionals, in combination with and controlled by compatible 0.55T MRI system software. The NeoCoil 12Ch Breast Coil can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures. When used as intended, the 12Ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making.

Source page: https://510kreport.com/device/K260947
Methodology: https://510kreport.com/methodology