# K183186: Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai United Imaging Healthcare Co., Ltd.
- Decided: Feb 8, 2019 after 81 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: 15 generations back to K971684 (1997). 54 ancestors in all.
No later device cites it as a predicate yet.
5 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163205: 48CH Head Coil, Ge Healthcare Coils (Usa Instruments, Inc.) (2017) Summary page 4.
- K181697: 16ch Foot/ Ankle SPEEDER, Quality Electrodynamics, LLC (2018) Summary page 5.
- K061952: Cardiovascular Array Coils, Models Cac-63-16, Cac-63-32, Cac-123-32 and Cac-127-16, Invivo (2006) Summary page 5.
- K133986: 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible Array, Resonance Innovations, LLC (2014) Summary page 5.
- K112002: Carotid Coil, Shanghai Chenguang Medical Technologies Co, Ltd. (2011) Summary page 5.
- K140998: Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil, Quality Electrodynamics, LLC (2014) Summary page 5.

## Indications for use
Head Coil - 12 is a 12 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Head Coil - 32 is a 32 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for head imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Carotid Coil - 8 is an 8 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for obtaining diagnostic images of carotid. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Temporomandibular Joint Coil - 4 is a 4 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for diagnostic images of the mandible region. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Infant Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Cardiac Coil - 24 is a 24 channel receive-only RF Coil designed for use with UIH 3.0T MRI systems. The indications for use include imaging of the heart, and mediastinum regions. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Foot & Ankle Coil - 24 is a 24 channel receive-only RF coil designed for use with UIH 3.0T MRI systems. The coil is indicated for use for foot and ankle imaging. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Source page: https://510kreport.com/device/K183186
Methodology: https://510kreport.com/methodology