# K122174: Pediatric Positioner Pad Set

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Coils (Usa Instruments, Inc.)
- Decided: Nov 16, 2012 after 116 days
- Product code: KXH (Cradle, Patient, Radiologic)
- Device class: 1
- Regulation: 21 CFR 892.1830
- 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 K930124 (1994). 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)
- K930124: Variant of Octostop and Octopaque, Octostop, Inc. (1994) Summary page 1.
- K030317: Model 1300GE-64: Pediatric Positioner, Midwest Rf, LLC (2003) Summary page 1.

## Indications for use
The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.OT GE MRI Systems for positioning of the pediatric patient.

Source page: https://510kreport.com/device/K122174
Methodology: https://510kreport.com/methodology