# K981959: Outlook Large Phased Array Neck Coil

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jul 31, 1998 after 57 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
Longest line of descent: 2 generations back to K925987 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964678: Phased Array Neck Coil, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.
- K964531: Profile 70000 Quadrature Volume Neck Coil, Us Asia Instruments, Inc. (1997) Summary page 2.

## Indications for use
The Picker Outlook system is intended 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. The Large Phased Array Neck Coil is indicated for use in providing coverage of the neck, from the cerebellum to the upper thoracic spine region. Anatomic Regions: Neck Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K981959
Methodology: https://510kreport.com/methodology