# K122897: Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Dec 21, 2012 after 91 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: 2 generations back to K954190 (1995). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093842: 1.5T and 3.0T General Purpose Flex Coils, Invivo Corporation (2010) Summary page 2.

## Most influential descendants
- K212864: dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T (2021), 2 descendants of its own
- K232021: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T (2023), 1 descendant of its own
- K260519: Smart Fit TorsoCardiac 1.5T (2026), 0 descendants of its own

## Indications for use
The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.

Source page: https://510kreport.com/device/K122897
Methodology: https://510kreport.com/methodology