# K113365: Infant Array

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Imaging Research Dba Sree Medical Systems
- Decided: Mar 29, 2012 after 135 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: 4 generations back to K001870 (2000). 5 ancestors in all.
2 later devices descend 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)
- K052621: 1.5T 16 Channel Brain-Spine Array Coil, Usa Instruments, Inc. (2005) Summary page 3.
- K093348: 3.0T 16 Channel Head Neck Spine Coil, Ge Healthcare Coils (Usa Instruments, Inc.) (2009) Summary page 3.

## Most influential descendants
- K140998: Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim Coil (2014), 1 descendant of its own
- 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 Infant Array when used in conjunction with GE, Siemens and Philips 1.51 and 3T1 MRI systems or Infant Array when used with the MRI compatible incubator and in conjunction with the abovementioned MLRI systems provide imaging of the infant's brain, spine, heart, torso and extremities. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis.

Source page: https://510kreport.com/device/K113365
Methodology: https://510kreport.com/methodology