# K974844: Outlook System Enhancement Package

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Mar 10, 1998 after 76 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: 3 generations back to K931544 (1993). 5 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.
- K964626: Edge/Vista System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.

## Most influential descendants
- 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
- K022007: Liberty 5000 Breast Coil with Disposable Biopsy Plates (2002), 2 descendants of its own

## Indications for use
The system enhancement package does not change the existing indications for the standard Outlook system as defined below. The Outlook 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/K974844
Methodology: https://510kreport.com/methodology