# K003655: PHS-63 Pediatric Head and Spine Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Mri Devices Corp.
- Decided: Feb 2, 2001 after 67 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K081322: Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine Coil (2008), 1 descendant of its own
- K101858: Pediatric Head-Spine Coil (Model:5000012701 (2010), 0 descendants of its own
- K071847: Magnetic Resonance Diagnostic Device, Model CG-KFC18-H150-AP - Knee/Foot/Ankle Coil (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K003655
Methodology: https://510kreport.com/methodology