# K123091: Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T

- Pathway: 510(k) (Traditional)
- Applicant: Imris, Inc.
- Decided: Dec 27, 2012 after 86 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: 7 generations back to K962061 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102155: MR Radiation Oncology Options, Ge Medical Systems, LLC (2010) Summary page 2.

## Indications for use
VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures. VISIUS Wireless Coils produce images of the 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/K123091
Methodology: https://510kreport.com/methodology