# K113474: 1.5T Gem Flex Coil

- Pathway: 510(k) (Abbreviated)
- Applicant: Neocoil, LLC
- Decided: Mar 16, 2012 after 115 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 K101632 (2010). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101632: Metaflexcoil, Neocoil, LLC (2010) Summary page 1.

## Most influential descendants
- K121362: 1.5T 16CH Flex Speeder Large (2012), 4 descendants of its own
- K252179: GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only (2026), 0 descendants of its own
- K244054: 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) (2025), 0 descendants of its own
- K141832: 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, Large (2014), 0 descendants of its own
- K133422: 1.5T 16-Channel Flex Coil, Small 1.5T 16-Channel Flex Coil, Large (2013), 0 descendants of its own

## Indications for use
To be used in conjunction with a GE 1.5 HD or DV Series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck, and spine in pediatric and adult populations that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K113474
Methodology: https://510kreport.com/methodology