# K023929: Magnetic Resonance Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Imaging Research, Inc.
- Decided: Feb 21, 2003 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: 1 generation back to K934396 (1993). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934396: Quadrature Lower Extremity Coil, Medical Advances, Inc. (1993) Summary page 1.
- K001312: Model 473SI-64E Quadrature Lower Extremity Coil, Igc-Medical Advances, Inc. (2000)

## Most influential descendants
- K091047: Neonate Array Coils (2010), 1 descendant of its own
- K171515: NHAC 16 (2017), 0 descendants of its own
- K083541: Neonate Head and Body Coils (2009), 0 descendants of its own
- K061281: Insight Head Coil (2006), 0 descendants of its own

## Indications for use
The RF coils when used in conjunction with the MRI systems or RF coils when used with the incubator system and both the incubator and RF coils used in conjunction with the MRI systems provide imaging of the adult head, extremity, neonate head and body. When interpreted by a trained physician, these images provide information that can be useful in the determination of the diagnosis. Anatomical Region: Adult Head, Extremity Neonate Head, Body (heart, spine, pelvis, extremity) Nucleus Excited: Proton 1H Diagnostic Uses: ID, 2D, 3D TI, T2 Weighting Proton Density Chemical Shift MR Blood Flow MR Spectroscopy

Source page: https://510kreport.com/device/K023929
Methodology: https://510kreport.com/methodology