# K103506: 1.5T Head Coil (HC150), 3T Head Coil (HC300)

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Feb 2, 2011 after 65 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: 8 generations back to K801623 (1980). 45 ancestors in all.
No later device cites it as a predicate yet.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091166: IMRX, Imris, Inc. (2009) Summary page 2.
- K083137: Neuro Iii-SV, Imris, Inc. (2008) Summary page 2.
- K061916: Neuro II-SE, Models or-MB-DR and or-DR, Imris, Inc. (2006) Summary page 2.
- K071099: Neuro II-SE, Models: or-DR-or, or-MB, Imris, Inc. (2007) Summary page 2.

## Indications for use
IMRIS Flex coils HC15O (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures. IMRIS Flex coils produce images of the human head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

Source page: https://510kreport.com/device/K103506
Methodology: https://510kreport.com/methodology