# K140998: Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil

- Pathway: 510(k) (Traditional)
- Applicant: Quality Electrodynamics, LLC
- Decided: Jul 11, 2014 after 84 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: 5 generations back to K001870 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K113365: Infant Array, Advanced Imaging Research Dba Sree Medical Systems (2012) Summary page 1.

## Most influential descendants
- K183186: Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 (2019), 0 descendants of its own

## Indications for use
The Pediatric 16 is intended for use with the Siemens I.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician

Source page: https://510kreport.com/device/K140998
Methodology: https://510kreport.com/methodology