# K951649: Model #801GE1500 Pediatric Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medic, Inc.
- Decided: Jun 22, 1995 after 73 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K133986: 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible Array (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
- K061170: 3.0T Pediatric Head and Spine Array, Model 808GE3000 (2006), 0 descendants of its own
- K060689: 1.5T Pediatric Head and Spine Array Model (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K951649
Methodology: https://510kreport.com/methodology