# K083541: Neonate Head and Body Coils

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Imaging Research, Inc.
- Decided: Feb 24, 2009 after 88 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: 2 generations back to K934396 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023929: Magnetic Resonance Diagnostic Device, Advanced Imaging Research, Inc. (2003) Summary page 2.

## Indications for use
The Neonate Coils when used in conjunction with the MRI systems or Neonate coils when used with the MRI compatible incubator and in conjunction with the MRI systems provide imaging of the infant head and body (torso). 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/K083541
Methodology: https://510kreport.com/methodology