# K030317: Model 1300GE-64: Pediatric Positioner

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Rf, LLC
- Decided: Mar 25, 2003 after 54 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122174: Pediatric Positioner Pad Set (2012), 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

## Indications for use
Magnetic Resonance Imaging (MRI), Magnetic Resonance Angiography (MRA) and Proton Spectroscopy of the pediatric head, body and extremities. This device is used in conjunction with a General Electric 1.5 Tesla MRI System. Proton Spectroscopy is used in conjunction with the PROBE (Proton Brain Exam) option.

Source page: https://510kreport.com/device/K030317
Methodology: https://510kreport.com/methodology