# K931544: 1.5T Edge and 1.0T Vista Systems

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Nov 22, 1993 after 238 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K954646: Epi-II System Option W/High Performance Gradients (1996), 18 descendants of its own
- 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

## Recalls of this device
- Sep 19, 2008 · Not classified · Z-2429-2010: Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.
- Sep 19, 2008 · Not classified · Z-2430-2010: Water may collect and freeze in the vent pipe. This can rupture the magnet vessel during a cryogen transfer, and release helium into the MRI suite.

Source page: https://510kreport.com/device/K931544
Methodology: https://510kreport.com/methodology