# K032415: Millennium Iii 4 Channel Neurovascular Coil

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Aug 25, 2003 after 20 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: 1 generation back to K001870 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001870: Millennium 9000 Phased Array Neurovascular Coil, Usa Instruments, Inc. (2000). Our reading of the summary gave K001807, FDA’s number for Tissue Marker (Advanced Uroscience, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Millennium 9000 Phased Array Neurovascular Coil”.

## Indications for use
The Millennium Ill 4 Channel Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium Ill 4 Channel Neurovascular Coil is designed for use with the GE 3.OT scanner manufactured by GE Medical Systems, Inc. Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The 3.OT MRI system 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 T I, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. 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/K032415
Methodology: https://510kreport.com/methodology