# K103342: 3.0T Metaflexcoil

- Pathway: 510(k) (Traditional)
- Applicant: Neocoil, LLC
- Decided: Dec 23, 2010 after 38 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K252876: GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only (2026), 0 descendants of its own

## Recalls of this device
- Dec 18, 2015 · Class II · Z-1027-2016: Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.

Source page: https://510kreport.com/device/K103342
Methodology: https://510kreport.com/methodology