# K983143: Mark 5000 Phased Array Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Nov 16, 1998 after 69 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 K893619 (1989). 8 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945778: Phased Array Shoulder Coil, Quadrature Shoulder Coil, Medical Advances, Inc. (1995) Summary page 2.
- K960497: Flexible Phased Array Spine Coil, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 2.
- K980157: Premier 7000 CTL Spine Coil, Usa Instruments, Inc. (1998) Summary page 2.
- K945827: Outlook, Philips Medical Systems (Cleveland), Inc. (1995) Summary page 2.
- K964531: Profile 70000 Quadrature Volume Neck Coil, Us Asia Instruments, Inc. (1997) Summary page 2.

## Most influential descendants
- K013854: Mark 5000 Quadrature Shoulder Coil (2002), 5 descendants of its own
- K033753: Pelvic Array Coil (2003), 4 descendants of its own
- K061715: Mrgfus General Purpose and Breast Coil (2006), 2 descendants of its own
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own
- K113280: Carotid Coil GE 1.5T (2011), 0 descendants of its own

## Indications for use
The Mark 5000 Phased Array Shoulder Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Phased Array Shoulder Coil is designed for use with the Outlook (.23 Tesla) MRI scanner manufactured by Picker International. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Picker Outlook system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, 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/K983143
Methodology: https://510kreport.com/methodology