# K070778: Neocoil 3.0T 6-Channel Carotid Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil
- Decided: Apr 11, 2007 after 21 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012491: Machnet Carotids Coil Array Assembly, Machnet BV (2001) Summary page 2.
- K052585: 3T HD Breast Array, Usa Instruments, Inc. (2005) Summary page 2.
- K042342: Millennium Iii 3T-8-Channel Neurovascular Coil, Usa Instruments, Inc. (2004) Summary page 2.

## Indications for use
The NeoCoil 3.QT 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.OT 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Tesla) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen. The indications for use are the same as for standard imaging: The GE scanner is indicated for use as an NMR device that produces images that: (1)correspond to the distribution of protons exhibiting NMR signal, (2)depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2, and (3)display the vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K070778
Methodology: https://510kreport.com/methodology