# K101632: Metaflexcoil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Aug 24, 2010 after 75 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K113474: 1.5T Gem Flex Coil (2012), 6 descendants of its own
- K121362: 1.5T 16CH Flex Speeder Large (2012), 4 descendants of its own
- K172222: 8ch Flex Suite (2017), 1 descendant 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

## Indications for use
To be used hii conjunction with a 1.5T GE HD or DV series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, head, neck and spine that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K101632
Methodology: https://510kreport.com/methodology