# K093842: 1.5T and 3.0T General Purpose Flex Coils

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Mar 5, 2010 after 80 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: 1 generation back to K954190 (1995). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954190: Model 580GE-64 Quadrature Abdominal Flex Coil, Medical Advances, Inc. (1995) Summary page 1.

## Most influential descendants
- K111673: 1.5T and 3T 8-Channel Medium General Purpose Flex Coil (2011), 5 descendants of its own
- K122897: Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645 (2012), 3 descendants of its own
- K120122: Sense MSK S 8CH 1.5T (2012), 3 descendants of its own
- 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

## Indications for use
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the hip, knee, ankle, chest, and pelvic regions, as an aid to diagnosis.

Source page: https://510kreport.com/device/K093842
Methodology: https://510kreport.com/methodology