# K954646: Epi-II System Option W/High Performance Gradients

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jan 18, 1996 after 100 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
Longest line of descent: 1 generation back to K931544 (1993). 2 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931544: 1.5T Edge and 1.0T Vista Systems, Philips Medical Systems (Cleveland), Inc. (1993) Summary page 4.
- K945828: Echo Planar Imaging I, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 4.

## Most influential descendants
- K964626: Edge/Vista System Enhancement Package (1997), 15 descendants of its own
- K974844: Outlook System Enhancement Package (1998), 11 descendants of its own
- K013858: Infinion 0.6T MR Imaging System (2002), 5 descendants of its own
- K024042: Panorama Enhancements (2003), 4 descendants of its own
- K983342: MR Guided Procedures (MRGP) Basic Package (1998), 4 descendants of its own

## Indications for use
The Picker International EDGE system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K954646
Methodology: https://510kreport.com/methodology