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Phased Array Knee and Foot Coil

by USA Instruments, Inc. United States 510(k)

510(k) K994040

Product code MOS

Overview

A Phased Array Knee and Foot Coil is a specialty magnetic resonance imaging (MRI) coil designed for imaging the knee and foot. It is classified as a Class II medical device under regulation number 892.1000 and product code MOS.

The device received FDA 510(k) clearance (K994040) on January 18, 2000, and is substantially equivalent to a legally marketed device. It is used in radiology settings and manufactured by USA Instruments, Inc. located in Aurora, Ohio.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994040 Date18 Jan 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
MOS
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from USA Instruments, Inc.

See all devices from USA Instruments, Inc. →

Questions

  • What is the Phased Array Knee and Foot Coil used for?

    It is a specialty magnetic resonance imaging (MRI) coil designed specifically for imaging the knee and foot, used in radiology settings to obtain detailed images of these anatomical areas.

  • Who manufactures the Phased Array Knee and Foot Coil and where are they located?

    The device is manufactured by USA Instruments, Inc., located at 1515 Danner Dr., Aurora, Ohio 44202, United States.

  • What regulatory pathway was used for the Phased Array Knee and Foot Coil?

    The device received FDA 510(k) clearance under submission K994040 on January 18, 2000, and was determined to be substantially equivalent to a legally marketed predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K994040 24 fields · synced 22 Oct 2026