# K061281: Insight Head Coil

- Pathway: 510(k) (Traditional)
- Applicant: Insight Neuroimaging Systems, LLC
- Decided: Jun 19, 2006 after 42 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 K002179 (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)
- K021330: Magnetom Trio Quadrature TX/RX Head Coil, Usa Instruments, Inc. (2002) Summary page 3.
- K023929: Magnetic Resonance Diagnostic Device, Advanced Imaging Research, Inc. (2003) Summary page 3.
- K040937: Tem 3000 Head Coil, Mr Instruments, Inc. (2004) Summary page 3.

## Indications for use
The Insight Head Coil is a quadrature transmitting and receiving device used to produce magnetic resonance images of the head regions that can be interpreted by a trained radiologist. This device provides a closed, ergonomic package with many patient friendly features including a shorter coil length so that no part of the coil will be over the patient's eyes, nose or mouth.

Source page: https://510kreport.com/device/K061281
Methodology: https://510kreport.com/methodology