# K101858: Pediatric Head-Spine Coil (Model:5000012701

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Chenguang Medical Technologies Co, Ltd.
- Decided: Jul 14, 2010 after 12 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 K003655 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081322: Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine Coil, Shanghai Chenguang Medical Technologies Co, Ltd. (2008) Summary page 1.

## Indications for use
The Pediatric Head-Spine Coil is a receive-only coil, used for obtaining diagnostic images of pediatric head and spine in magnetic resonance imaging systems. This coil is designed to be used in a Philips Achieva MRI 3.OT system. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K101858
Methodology: https://510kreport.com/methodology