# K013854: Mark 5000 Quadrature Shoulder Coil

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Feb 6, 2002 after 78 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: 3 generations back to K893619 (1989). 13 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K983143: Mark 5000 Phased Array Shoulder Coil, Usa Instruments, Inc. (1998). Our OCR of the scanned summary read K893143, FDA’s number for Latex Exam Gloves (MFG. Guangdong Zhongshan) (Guangzhou Chemicals Import & Export Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mark 5000 Phased Array Shoulder Coil”.
- K992650: Airis, Airis II, Hitachi Medical Systems America, Inc. (1999) Summary page 2.

## Most influential descendants
- 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
- K071966: 1.5T Mrgfus Pelvic Coil (2007), 0 descendants of its own

## Indications for use
The Mark 5000 Quadrature Shoulder Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the shoulder and surrounding regions in Magnetic Resonance Imaging systems. The Mark 5000 Quadrature Shoulder Coil is designed for use with the Toshiba Opart 0.35Tesla MRI scanner manufactured by Toshiba Medical Systems, Inc. Anatomic Regions: Shoulder and surrounding regions. Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Toshiba Opart MRI 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/K013854
Methodology: https://510kreport.com/methodology