# K140282: ST Sense NV 8 Array Coil

- Pathway: 510(k) (Special)
- Applicant: Resonance Innovations, LLC
- Decided: Feb 26, 2014 after 22 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 1.57T Pediatric Head/Spine Array Coil: named in the summary without a submission number

## Indications for use
The intended use for this L OT 8-channel Neurovascular Coil is to facilitate diagnostic targeting imaging of'brain, neck and upper chest that may be interpreted by a trained physician. -To collect image data throughout the region of the head, neck and chest region of the patient using a Philips vertical-field ILOT MR scanner. *Various regions of the Brain, including brainstem. pituitary. JAC. and orbits, intra cerebral vascular structure, soft tissue of the facial area, arteries between the aortic arch and the Circle of Willis, soft tissue in the anterior neck, pediatric head/neck, cervical spine, long top and brachial plexus, and with the ability to scan feet and ankles.

Source page: https://510kreport.com/device/K140282
Methodology: https://510kreport.com/methodology