# K964626: Edge/Vista System Enhancement Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 10, 1997 after 83 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931544 (1993). 3 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 19 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 2.
- K954646: Epi-II System Option W/High Performance Gradients, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.

## Most influential descendants
- 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
- K071154: Superstar 0.35T Mri System (2007), 3 descendants of its own

## Recalls of this device
- Aug 7, 2013 · Class II · Z-0033-2014: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.
- Sep 19, 2008 · Not classified · Z-2431-2010: 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-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.

## Indications for use
The Picker International EDGE and VISTA systems are 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/K964626
Methodology: https://510kreport.com/methodology